S1200: Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Pts W/Early-Stage Breast Cancer

NCT01535066 | Completed DMC

• 4 other identifiers: S1200R01AT000636-01U10CA037429NCI-2012-00251
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 47

Brief Summary

RATIONALE: Acupuncture may help relieve joint pain. PURPOSE: This randomized phase III trial studies acupuncture to see how well it works compared to sham acupuncture or waitlist in treating patients with joint pain related to aromatase inhibitors in patients with early-stage breast cancer.

Conditions

Breast Cancer; Pain

Keywords

estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; pain

Outcome Measures

Primary Outcomes (1)

• Decrease of joint pain associated with the use of AIs as measured by BPI-SF

  6 weeks

Secondary Outcomes (6)

• Benefit of acupuncture maintenance as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG

  6, 12, 16, 20, and 24 weeks

• Durability of response as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG

  52 weeks.

• Long-term effects of acupuncture as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG

  52 weeks

• Analgesic and opioid use

  2, 4, 6, 12, 16, 20, 24, and 52 weeks

• AI adherence

  12, 24, and 52 weeks

Study Arms (3)

Arm I

EXPERIMENTAL

Patients receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.

Procedure: acupuncture therapy

Arm II

SHAM COMPARATOR

Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.

Procedure: sham acupuncture

Arm III

NO INTERVENTION

Patients are assigned to a waiting list for 12 weeks with standard follow-up care.

Interventions

acupuncture therapy PROCEDURE

Receive acupuncture

Arm I

sham acupuncture PROCEDURE

Receive sham acupuncture

Arm II

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Patients must be women with histologically confirmed primary invasive carcinoma of the breast (Stage I, II, or III) with no evidence of metastatic disease (M0); patients must have undergone modified radical mastectomy or breast-sparing surgery; patients must have recovered from all side-effects of the surgery * Patients must be positive for estrogen receptor (ER) and/or progesterone receptor (PgR) as determined by institutional standard * Patients must currently be taking a third-generation aromatase inhibitor (AI) - anastrozole, letrozole, or exemestane for at least the previous 90 days prior to registration with plans to continue for at least an additional 1 year after registration; patients may have switched AIs provided that they have been on a stable dose for at least 90 days; concurrent trastuzumab (Herceptin) is allowed * Patients must have completed the S1200 Brief Pain Inventory-Short Form (BPI-SF) within 14 days prior to registration; patients must have a worst pain score of at least 3 on the Brief Pain Inventory (item #2) that has started or increased since starting AI therapy * Patients must be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFα, IL-6, IL-12, CRP and urine CTX-II), urine AI metabolites, and DNA analysis (CYP19A1), and must be given the option to consent to use of remaining specimens for future translational medicine studies; baseline samples must be obtained prior to beginning intervention PATIENT CHARACTERISTICS: * Patients must be postmenopausal, as defined by at least one of the following: * ≥ 12 months since the last menstrual period * Prior bilateral oophorectomy * Current use of a gonadotropin-releasing hormone (GnRH) agonist * Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the postmenopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration * Patients must have a Zubrod performance status of 0 to 1 * Patients must not have a severe bleeding disorder * Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), gout, episodes of acute monoarticular arthritis clinically consistent with pseudogout, Paget disease affecting the study joint (knees/hands), a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson disease, hemochromatosis, alkaptonuria, or primary osteochondromatosis * 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 have a history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient * Patients must be able to complete study questionnaires in English or Spanish * No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ \[DCIS\], adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer for which the patient has been disease-free for \> 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Patients must not have had prior acupuncture treatment within the past 12 months or for AI-induced joint symptoms at any time * Patients must not be on narcotics within 14 days of registration * Patients must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids within 28 days prior to registration * Patients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates or tramadol, with the exception of nonsteroidal anti-inflammatory drugs \[NSAIDs\] and acetaminophen) within 14 days prior to registration * Patients must not have received or implemented any other medical therapy, alternative therapy, or physical therapy for the treatment of joint pain/stiffness within 28 days prior to registration; therapeutic massage is allowed

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
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (47)

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Kaiser Permanente, Fremont

Fremont, California, 94538, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente - Sacramento

Sacramento, California, 95825, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, 83642, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Bronson Battle Creek

Battle Creek, Michigan, 49017, United States

Location

Spectrum Health Big Rapids Hospital

Big Rapids, Michigan, 49307, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Mercy Health Mercy Campus

Muskegon, Michigan, 49444, United States

Location

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, 29650, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States

Location

Related Publications (2)

• Hershman DL, Unger JM, Greenlee H, Capodice J, Lew DL, Darke A, Minasian LM, Fisch MJ, Henry NL, Crew KD. Comparison of Acupuncture vs Sham Acupuncture or Waiting List Control in the Treatment of Aromatase Inhibitor-Related Joint Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2241720. doi: 10.1001/jamanetworkopen.2022.41720.

  PMID: 36367721 DERIVED

• Hershman DL, Unger JM, Greenlee H, Capodice JL, Lew DL, Darke AK, Kengla AT, Melnik MK, Jorgensen CW, Kreisle WH, Minasian LM, Fisch MJ, Henry NL, Crew KD. Effect of Acupuncture vs Sham Acupuncture or Waitlist Control on Joint Pain Related to Aromatase Inhibitors Among Women With Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):167-176. doi: 10.1001/jama.2018.8907.

  PMID: 29998338 DERIVED

Related Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Dawn Hershman, MD

  Herbert Irving Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 17, 2012
• Study Start: May 16, 2012
• Primary Completion: June 15, 2017
• Study Completion: July 1, 2018
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

US (47)