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Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Patients with Early-Stage Breast Cancer

Trial Status: Complete

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. Acupuncture may help relieve joint pain.

Inclusion Criteria

  • 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) or with histologically confirmed ductal carcinoma in situ (DCIS); if patient has undergone breast cancer surgery, she must have recovered from all side-effects of surgery
  • Patients must be postmenopausal, as defined by at least one of the following: * >= 12 months since the last menstrual period OR * Prior bilateral oophorectomy OR * Current use of a GnRH agonist OR * Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND 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 be positive for either 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 30 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 30 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 have a Zubrod performance status of 0 to 1
  • Patients must have had two or fewer acupuncture treatments within the past 12 months for any reason except for joint symptoms; patients must not have had prior acupuncture treatment for joint symptoms at any time
  • Patients must not have a severe bleeding disorder
  • Patients must not have an allergy to latex
  • 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's disease affecting the study joint (knees/hands), a history of septic arthritis or avascular necrosis or intra-articular fracture of the study joint, Wilson's 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 not be on narcotics within 14 days of registration
  • Patients must not have received oral corticosteroids, intramuscular corticosteroids, or intra-articular steroids for joint symptoms within 28 days prior to registration
  • Patients must not have received topical analgesics (e.g., capsaicin preparations) or any other analgesics (e.g., opiates, tramadol, with the exception of nonsteroidal anti-inflammatory drugs [NSAIDs], combination 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
  • 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
  • Prestudy history and physical must be obtained within 180 days prior to registration
  • Patients must be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFalpha, IL-6, IL-12, CRP and urine CTX-II),urine AI metabolites, and deoxyribonucleic acid (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
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the database

California

Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Fremont
Kaiser Permanente-Fremont
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Los Angeles
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Christy Ann Russell
Phone: 323-865-0451
Oakland
Kaiser Permanente-Oakland
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Redwood City
Kaiser Permanente-Redwood City
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Richmond
Kaiser Permanente-Richmond
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Roseville
Kaiser Permanente-Roseville
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Sacramento
Kaiser Permanente - Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Kaiser Permanente-South Sacramento
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
San Francisco
Kaiser Permanente-San Francisco
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
San Leandro
Kaiser Permanente San Leandro
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
San Rafael
Kaiser Permanente-San Rafael
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
South San Francisco
Kaiser Permanente-South San Francisco
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Stockton
Kaiser Permanente-Stockton
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Vallejo
Kaiser Permanente-Vallejo
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: CLOSED_TO_ACCRUAL
Contact: Louis Fehrenbacher
Phone: 626-564-3455

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: CLOSED_TO_ACCRUAL
Contact: Gary E. Goodman
Phone: 206-215-3086
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: CLOSED_TO_ACCRUAL
Contact: Gary E. Goodman
Phone: 206-215-3086

Massachusetts

Burlington
Lahey Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Corrine Lenahan Zarwan
Phone: 781-744-8027

Michigan

Battle Creek
Bronson Battle Creek
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Big Rapids
Spectrum Health Big Rapids Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Gilbert D.A. Padula
Phone: 330-375-6101
Grand Rapids
Cancer Research Consortium of West Michigan NCORP
Status: ADMINISTRATIVELY_COMPLETE
Contact: Gilbert D.A. Padula
Phone: 616-685-5225
Mercy Health Saint Mary's
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Kalamazoo
Borgess Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Muskegon
Mercy Health Mercy Campus
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Reed City
Spectrum Health Reed City Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Traverse City
Munson Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230
Wyoming
Metro Health Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Kathleen J. Yost
Phone: 616-391-1230

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Dawn Lauryn Hershman
Phone: 212-305-8615

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Vuky
Phone: 503-299-6500
Portland
Legacy Good Samaritan Hospital and Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Vuky
Phone: 503-299-6500
Tualatin
Legacy Meridian Park Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Vuky
Phone: 503-299-6500

South Carolina

Easley
Prisma Health Cancer Institute - Easley
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Greenville
Greenville Health System Cancer Institute-Andrews
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Prisma Health Cancer Institute - Butternut
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Prisma Health Cancer Institute - Eastside
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Prisma Health Cancer Institute - Faris
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Prisma Health Greenville Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Greer
Prisma Health Cancer Institute - Greer
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Seneca
Prisma Health Cancer Institute - Seneca
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: CLOSED_TO_ACCRUAL
Contact: Mark Allen O'Rourke
Phone: 864-241-6251

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL
Contact: Anna C. Beck
Phone: 801-581-4477

Washington

Seattle
Fred Hutchinson Cancer Research Center
Status: CLOSED_TO_ACCRUAL
Contact: Julie Ruth Gralow
Phone: 800-804-8824
Seattle Cancer Care Alliance
Status: CLOSED_TO_ACCRUAL
Contact: Julie Ruth Gralow
Phone: 800-804-8824
Swedish Medical Center-First Hill
Status: CLOSED_TO_ACCRUAL
Contact: Gary E. Goodman
Phone: 206-215-3086
Vancouver
Legacy Salmon Creek Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Jacqueline Vuky
Phone: 503-299-6500

PRIMARY OBJECTIVES:

I. To determine whether true acupuncture administered twice weekly for 6 weeks (8-12 sessions) compared to sham acupuncture and waitlist control causes a significant reduction in joint pain related to aromatase inhibitors (AIs) in women with early-stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain score at 6 weeks.

SECONDARY OBJECTIVES:

I. To investigate the effects of true acupuncture administered twice weekly for 6 weeks (8-12 sessions) followed by 6 weekly treatments (4-6 sessions) of maintenance (12-18 sessions total over 12 weeks) compared to sham acupuncture and waitlist control in this study population.

II. To evaluate the effects of acupuncture on the BPI-SF worst pain, worst stiffness, pain severity, and pain-related interference scores at 6, 12, 16, 20, 24, and 52 weeks.

III. To evaluate the effects of acupuncture on Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index (pain, stiffness, and function) for the hips and knees at 6, 12, 24, and 52 weeks.

IV. To evaluate the effects of acupuncture on Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) (pain, stiffness, and function) at 6, 12, 24, and 52 weeks.

V. To evaluate the effects of acupuncture on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Impact-Short Form (PROMIS PI-SF) at 6, 12, 24, and 52 weeks.

VI. To evaluate the effects of acupuncture on quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy-Endocrine Subscales (FACT-ES) at 6, 12, 24, and 52 weeks.

VII. To evaluate the effects of acupuncture on functional testing with grip strength and “Timed Get Up and Go” (TGUG) test at 6, 12, 24, and 52 weeks.

VIII. To evaluate the effects of acupuncture on analgesic and opioid use at 2, 4, 6, 12, 16, 20, 24, and 52 weeks.

IX. To evaluate the effects of acupuncture on self-reported AI adherence at 12, 24, and 52 weeks.

X. To assess AI adherence via urine AI metabolites at baseline, 24, and 52 weeks.

XI. To evaluate the effects of acupuncture on serum hormones (estradiol, follicle stimulating hormone [FSH], luteinizing hormone [LH]) and inflammatory biomarkers (serum tumor necrosis factors [TNF] alpha, interleukin [IL]-6, IL-12, C-reactive protein [CRP], and urine c-telopeptides of type II collagen [CTX-II]) at 6, 12, and 24 weeks.

XII. To evaluate whether polymorphisms in cytochrome P450, family 19, subfamily A, polypeptide 1 (CYP19A1) aromatase gene predict severity of AI-related joint symptoms.

XIII. To assess the safety and tolerability of acupuncture in this study population.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.

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

Arm III: Patients are assigned to a waiting list for 12 weeks.

After completion of study treatment, patients are followed up at 24 and 52 weeks.

Trial Phase Phase III

Trial Type Supportive care

Lead Organization
SWOG

Principal Investigator
Dawn Lauryn Hershman

  • Primary ID S1200
  • Secondary IDs NCI-2012-00251, SWOG-S1200, CDR0000725249
  • Clinicaltrials.gov ID NCT01535066