Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial
3 other identifiers
interventional
464
1 country
280
Brief Summary
RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors. PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jul 2011
Typical duration for phase_3 breast-cancer
280 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedResults Posted
Study results publicly available
August 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedFebruary 7, 2019
January 1, 2019
2.1 years
June 17, 2011
December 8, 2016
January 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks
The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1="none", 2="mild", 3="moderate", 4="severe" and 5="very severe" to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline).
At baseline and 12 weeks
Study Arms (3)
Arm I low dose DHEA
EXPERIMENTALParticipants apply a low dose (3.25 mg) of vaginal prasterone (dehydroepiandrosterone \[DHEA\]) gel once daily (QD), at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm II high dose DHEA
EXPERIMENTALParticipants apply a high dose (6.5 mg) of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Arm III placebo
PLACEBO COMPARATORParticipants apply a vaginal placebo gel QD, at bed time, for 12 weeks. There is an Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks. Treatment continues until unacceptable adverse events or patient refusal to continue participation on the study.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease). Note: Postmenopausal status will be determined by the following criteria:
- months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study
- menopausal status will be determined by an FSH and an estradiol value in the postmenopausal range (generally FSH \> 40IU/L and estradiol \< 10 pg/ml, depending on laboratory) if:
- months without a period or
- post hysterectomy with at least one ovary remaining and less than 55 years old. Note: if age 55 or older with these criteria, then menopausal status does not need to be determined by labs
- Significant vaginal complaints. Note: Defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention.
- Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia. The protocol contains more information.
- Vaginal symptoms must have been present ≥ 2 months prior to randomization.
- Life expectancy \> 12 months.
- Ability to complete questionnaires by themselves or with assistance.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- The patient must provide informed written consent.
- Willing to return to the enrolling institution for follow-up.
- Willing to provide blood samples for correlative research purposes.
You may not qualify if:
- Initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plans to initiate or discontinue any of these medications during the 12-week study.
- Current diagnosis of an active vaginal infection, if symptoms of vaginal infection, this must be ruled out (ie, foul discharge, fever).
- Concurrent chemotherapy (long term adjuvant herceptin, lapatanib, and/or bevacizumab is allowed.
- Planned use of any vaginal preparations during the study period (including any over the counter or herbal preparations). Note: Water-based lubricants (such as KY jelly) are allowed during sexual intercourse.
- Use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry.
- Exception: Daily water-based lubricants for sexual intercourse. Note: Patients who stop agent may be enrolled after one week.
- Current (≤ 4 weeks prior to randomization), or planned during the study period, use of any estrogen product or any kind of hormonal vaginal product including bioidentical hormones, estriol or any androgen product.
- Use of pharmacologic soy or phytoestrogen preparations (Dietary intake of soy - ie milk is acceptable).
- On a placebo controlled trial for endocrine therapy.
- Prior or concurrent pelvic radiation therapy.
- Prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration (TAH/BSO) is allowed).
- Diagnosis of any of the following conditions within the past five years:
- Essential vulvodynia
- Vulvar vestibulitis
- Bartholin cyst/abscess
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alliance for Clinical Trials in Oncologylead
- National Cancer Institute (NCI)collaborator
- Mayo Cliniccollaborator
Study Sites (280)
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Herbert D. Kerman Regional Oncology Center - Daytona Beach
Daytona Beach, Florida, 32114, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center - East
Honolulu, Hawaii, 96817, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Pacific Cancer Institute - Maui
Wailuku, Hawaii, 96793, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Idaho Urologic Institute, PA
Meridian, Idaho, 83642, United States
Illinois CancerCare - Bloomington
Bloomington, Illinois, 61701, United States
St. Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare - Canton
Canton, Illinois, 61520, United States
Illinois CancerCare - Carthage
Carthage, Illinois, 62321, United States
Eureka Community Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare - Eureka
Eureka, Illinois, 61530, United States
Galesburg Clinic, PC
Galesburg, Illinois, 61401, United States
Illinois CancerCare - Havana
Havana, Illinois, 62644, United States
Illinois CancerCare - Kewanee Clinic
Kewanee, Illinois, 61443, United States
Illinois CancerCare - Macomb
Macomb, Illinois, 61455, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Moline, Illinois, 61265, United States
Unknown Facility
Moline, Illinois, 61265, United States
Illinois CancerCare - Monmouth
Monmouth, Illinois, 61462, United States
OSF Holy Family Medical Center
Monmouth, Illinois, 61462, United States
BroMenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare - Community Cancer Center
Normal, Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa, Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Illinois CancerCare - Pekin
Pekin, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare - Peru
Peru, Illinois, 61354, United States
Illinois Valley Community Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare - Princeton
Princeton, Illinois, 61356, United States
Illinois CancerCare - Spring Valley
Spring Valley, Illinois, 61362, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
St. Francis Hospital Cancer Care Services
Indianapolis, Indiana, 46237, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391, United States
Unknown Facility
Bettendorf, Iowa, 52722, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center - West Lakes
Clive, Iowa, 50325, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, 48123-2500, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Foote Memorial Hospital
Jackson, Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing, Michigan, 48912-1811, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, 48601, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085, United States
St. John Macomb Hospital
Warren, Michigan, 48093, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
St. Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Duluth Clinic
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Immanuel St. Joseph's
Mankato, Minnesota, 56002, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
Coborn Cancer Center
Saint Cloud, Minnesota, 56303, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
Mercy Clinic Cancer and Hematology - Rolla
Rolla, Missouri, 65401, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65804, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, 87110, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, 88011, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
MeritCare Broadway
Fargo, North Dakota, 58102, United States
Dakota Cancer Institute at Dakota Clinic - South University
Fargo, North Dakota, 58103, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
CCOP - Columbus
Columbus, Ohio, 43215, United States
Grant Medical Center Cancer Care
Columbus, Ohio, 43215, United States
Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
CCOP - Dayton
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, 45662, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Willamette Falls Hospital
Oregon City, Oregon, 97045, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18105, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, 18201, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, 16801, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
AnMed Cancer Center
Anderson, South Carolina, 29621, United States
Bon Secours St. Francis Health System
Greenville, South Carolina, 29601, United States
Carolina Blood and Cancer Care Associates, PA
Lancaster, South Carolina, 29720, United States
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, 98664, United States
Northwest Cancer Specialists at Vancouver Cancer Center
Vancouver, Washington, 98684, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, 54601, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Debra Barton, R.N., Ph.D.
- Organization
- Alliance for Clinical Trials in Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Debra Barton, RN, PhD, AOCN, FAAN
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2011
First Posted
June 20, 2011
Study Start
July 1, 2011
Primary Completion
August 1, 2013
Study Completion
November 1, 2017
Last Updated
February 7, 2019
Results First Posted
August 25, 2017
Record last verified: 2019-01