S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy

NCT01385137 | Completed Phase 3 Results DMC

• 2 other identifiers: S0927U10CA037429
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 292

Brief Summary

RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and bone pain and stiffness caused by hormone therapy in patients with breast cancer. PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III breast cancer receiving hormone therapy.

Conditions

Arthralgia; Breast Cancer; Pain

Keywords

estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; pain; arthralgia

Outcome Measures

Primary Outcomes (1)

• Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score

  Linear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10

  12 weeks post-registration

Secondary Outcomes (4)

• Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug

  Up to 25 weeks

• Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

  12 weeks post-registration

• Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score

  12 weeks post-registration

• Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score

  12 weeks post-registration

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: omega-3 fatty acid

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.

Other: placebo

Interventions

omega-3 fatty acid DIETARY_SUPPLEMENT

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary invasive adenocarcinoma of the breast * Stage I, II, or IIIA disease * No metastatic disease * Must have undergone modified radical mastectomy or breast-sparing surgery and recovered * Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) * Currently taking a third-generation aromatase inhibitor (AI) \[e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)\] for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration * Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of ≥ 5 on the BPI (item #2) that has started or increased with AI therapy PATIENT CHARACTERISTICS: * Postmenopausal * Zubrod performance status 0-2 * Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1) * Able to complete study questionnaires in English * At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission * Patients must not have a known allergy to soy, given that the placebo is suspended in soybean oil PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study * More than 28 days since prior investigational agents * No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days * Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration * Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration * Patients must not be on narcotics within 14 days of registration * Patients may have received corticosteroid treatment; however, the following criteria apply: * Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration * Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration * Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days prior to registration

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (292)

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Highlands Oncology Group - Springdale

Rogers, Arkansas, 72758, United States

Location

Kaiser Permanente Medical Center - Anaheim/Orange County

Anaheim, California, 92807, United States

Location

Kaiser Permanente - Deer Valley

Antioch, California, 94531, United States

Location

Kaiser Permanente Medical Center - Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente Medical Center - Bellflower

Bellflower, California, 90706, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Kaiser Permanente Medical Center - Fontana

Fontana, California, 92335, United States

Location

Kaiser Permanente - Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente Fresno Medical Center

Fresno, California, 93720, United States

Location

Kaiser Permanente Medical Center - Harbor City

Harbor City, California, 90710, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Kaiser Permanente - Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, 90027, United States

Location

Kaiser Foundation Hospital - West Los Angeles

Los Angeles, California, 90034, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

Mercy Cancer Center at Mercy Medical Center

Merced, California, 95340, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Sutter Health - Western Division Cancer Research Group

Novato, California, 94945, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Kaiser Permanente Medical Center - Oakland

Oakland, California, 94611, United States

Location

Epic Care - Oakland

Oakland, California, 94612, United States

Location

Kaiser Permanente Medical Group

Panorama City, California, 91402, United States

Location

Valley Medical Oncology Consultants - Pleasanton

Pleasanton, California, 94588, United States

Location

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente Medical Center - Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente Medical Center - Riverside

Riverside, California, 92505, United States

Location

Kaiser Permanente Medical Center - Roseville

Roseville, California, 95661, United States

Location

Sutter Cancer Center at Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, 95823, United States

Location

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92108, United States

Location

Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, 94115, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, 95119, United States

Location

Kaiser Permanente Health Care

San Marcos, California, 92078, United States

Location

Doctors Medical Center - San Pablo Campus

San Pablo, California, 94806, United States

Location

Kaiser Foundation Hospital - San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, 95051, United States

Location

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, 95403, United States

Location

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente Medical Facility - Stockton

Stockton, California, 95210, United States

Location

Tahoe Forest Cancer Center

Truckee, California, 96161, United States

Location

Kaiser Permanente Medical Center - Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

Sutter Solano Medical Center

Vallejo, California, 94589, United States

Location

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, 94596, United States

Location

Kaiser Permanente Medical Cener - Woodland Hills

Woodland Hills, California, 91367, United States

Location

Kaiser Permanente - Denver

Denver, Colorado, 80205, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Front Range Cancer Specialists

Fort Collins, Colorado, 80528, United States

Location

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, 33316, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Kaiser Permanente - Moanalua Medical Center and Clinic

Honolulu, Hawaii, 96819, United States

Location

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, 83619, United States

Location

St. Joseph Regional Medical Center

Lewiston, Idaho, 83501, United States

Location

Mountain States Tumor Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Saint Luke's Mountain States Tumor Institute

Nampa, Idaho, 83686, United States

Location

Mountain States Tumor Institute at St. Luke's

Twin Falls, Idaho, 83301, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864, United States

Location

Edward Hospital Cancer Center

Naperville, Illinois, 60540, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Reid Hospital & Health Care Services

Richmond, Indiana, 47374, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Cancer Center of Kansas, PA - Liberal

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Saint Luke's Hospital - South

Overland Park, Kansas, 66213, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

CCOP - Kansas City

Prairie Village, Kansas, 66208, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67401, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503-9985, United States

Location

CHRISTUS Cabrini Cancer Center

Alexandria, Louisiana, 71301, United States

Location

Louisiana State University Health Sciences Center - Monroe

Monroe, Louisiana, 71210, United States

Location

Highland Clinic

Shreveport, Louisiana, 71105, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, 48106-0995, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, 48123-2500, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

McLaren Cancer Institute

Flint, Michigan, 48532, United States

Location

Singh and Arora Hematology Oncology, PC

Flint, Michigan, 48532, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Foote Memorial Hospital

Jackson, Michigan, 49201, United States

Location

Sparrow Regional Cancer Center

Lansing, Michigan, 48912-1811, United States

Location

Great Lakes Cancer Institute - Lapeer Campus

Lapeer, Michigan, 48446, United States

Location

St. Mary Mercy Hospital

Livonia, Michigan, 48154, United States

Location

Clemens Regional Medical Center

Mount Clemens, Michigan, 48043, United States

Location

Mercy General Health Partners

Muskegon, Michigan, 49444, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Joseph Mercy Oakland

Pontiac, Michigan, 48341-2985, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Central Care Cancer Center at Carrie J. Babb Cancer Center

Bolivar, Missouri, 65613, United States

Location

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States

Location

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

North Kansas City Hospital

Kansas City, Missouri, 64116, United States

Location

Heartland Hematology Oncology Associates, Incorporated

Kansas City, Missouri, 64118, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, 64086, United States

Location

Parvin Radiation Oncology

Liberty, Missouri, 64068, United States

Location

Phelps County Regional Medical Center

Rolla, Missouri, 65401, United States

Location

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Midwest Hematology Oncology Group, Incorporated

St Louis, Missouri, 63109, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59102, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, 68848-1990, United States

Location

Lovelace Medical Center - Downtown

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Falck Cancer Center at Arnot Ogden Medical Center

Elmira, New York, 14905, United States

Location

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, 10940-4199, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Randolph Hospital

Asheboro, North Carolina, 27203-5400, United States

Location

Mission Hospitals - Memorial Campus

Asheville, North Carolina, 28801, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

CaroMont Cancer Center at Gaston Memorial Hospital

Gastonia, North Carolina, 28053, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Moses Cone Regional Cancer Center at Wesley Long Community Hospital

Greensboro, North Carolina, 27403-1198, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Medical Center Cancer Care

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

CCOP - Dayton

Dayton, Ohio, 45420, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Knox Community Hospital

Mount Vernon, Ohio, 43050, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Southern Ohio Medical Center Cancer Center

Portsmouth, Ohio, 45662, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, 43081, United States

Location

United States Air Force Medical Center - Wright-Patterson

Wright-Patterson AFB, Ohio, 45433-5529, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

St. Charles Medical Center - Bend

Bend, Oregon, 97701, United States

Location

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Providence Newberg Medical Center

Newberg, Oregon, 97132, United States

Location

Willamette Falls Hospital

Oregon City, Oregon, 97045, United States

Location

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland, Oregon, 97227, United States

Location

Salem Hospital Regional Cancer Care Services

Salem, Oregon, 97309-5014, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29501, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, 29605, United States

Location

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Self Regional Cancer Center at Self Regional Medical Center

Greenwood, South Carolina, 29646, United States

Location

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, 29650, United States

Location

Carolina Blood and Cancer Care Associates, PA

Lancaster, South Carolina, 29720, United States

Location

Carolina Blood and Cancer Care

Rock Hill, South Carolina, 29732, United States

Location

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, 29672, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Baylor University Medical Center - Dallas

Dallas, Texas, 75246, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Baylor Medical Center at Irving

Irving, Texas, 75061, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Sandra L. Maxwell Cancer Center

Cedar City, Utah, 84720, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Island Hospital Cancer Care Center at Island Hospital

Anacortes, Washington, 98221, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Highline Medical Center Cancer Center

Burien, Washington, 98166, United States

Location

Providence Centralia Hospital

Centralia, Washington, 98531-9027, United States

Location

Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

Location

St. Francis Hospital

Federal Way, Washington, 98003, United States

Location

Swedish Medical Center - Issaquah Campus

Issaquah, Washington, 98029, United States

Location

Columbia Basin Hematology

Kennewick, Washington, 99336, United States

Location

Cascade Cancer Center at Evergreen Hospital Medical Center

Kirkland, Washington, 98033, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98274, United States

Location

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, 98506-5166, United States

Location

Harrison Poulsbo Hematology and Onocology

Poulsbo, Washington, 98370, United States

Location

Good Samaritan Cancer Center

Puyallup, Washington, 98372, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Pacific Medical Center

Seattle, Washington, 98104, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Evergreen Hematology and Oncology, PS

Spokane, Washington, 99218, United States

Location

Franciscan Cancer Center at St. Joseph Medical Center

Tacoma, Washington, 98405-3004, United States

Location

Allenmore Hospital

Tacoma, Washington, 98405, United States

Location

CCOP - Northwest

Tacoma, Washington, 98405, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

St. Clare Hospital

Tacoma, Washington, 98499, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98664, United States

Location

Legacy Salmon Creek Medical Center

Vancouver, Washington, 98686, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States

Location

Rocky Mountain Oncology

Casper, Wyoming, 82609, United States

Location

Related Publications (1)

• Hershman DL, Unger JM, Crew KD, Awad D, Dakhil SR, Gralow J, Greenlee H, Lew DL, Minasian LM, Till C, Wade JL 3rd, Meyskens FL, Moinpour CM. Randomized Multicenter Placebo-Controlled Trial of Omega-3 Fatty Acids for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain: SWOG S0927. J Clin Oncol. 2015 Jun 10;33(17):1910-7. doi: 10.1200/JCO.2014.59.5595. Epub 2015 May 4.

  PMID: 25940724 DERIVED

MeSH Terms

Conditions

Arthralgia; Breast Neoplasms; Pain

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Dawn Hershman, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

• Laurence H. Baker, DO, FACOI

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 7, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (292)