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

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ClinicalTrials.gov Identifier: NCT01535066
Recruitment Status : Completed
First Posted : February 17, 2012
Last Update Posted : December 11, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Southwest Oncology Group

Tracking Information
First Submitted Date  ICMJE February 14, 2012
First Posted Date  ICMJE February 17, 2012
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE March 27, 2012
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
Decrease of joint pain associated with the use of AIs as measured by BPI-SF [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
Decrease of joint pain associated with the use of AIs at 6 weeks as measured by BPI-SF
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2013)
  • Benefit of acupuncture maintenance as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 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 [ Time Frame: 52 weeks. ]
  • Long-term effects of acupuncture as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 52 weeks ]
  • Analgesic and opioid use [ Time Frame: 2, 4, 6, 12, 16, 20, 24, and 52 weeks ]
  • AI adherence [ Time Frame: 12, 24, and 52 weeks ]
  • Safety and tolerability of acupuncture [ Time Frame: 2, 4, 6, 12, 16, 20, 24, and 52 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
  • Benefit of acupuncture maintenance as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG
  • Durability of response as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG
  • Long-term effects of acupuncture as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG
  • Analgesic and opioid use at 2, 4, 6, 12, 16, 20, 24, and 52 weeks
  • AI adherence at 12, 24, and 52 weeks
  • Safety and tolerability of acupuncture
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE S1200: Acupuncture, Sham Acupuncture, or Wait List for Joint Symptoms Related to Aromatase Inhibitors in Pts W/Early-Stage Breast Cancer
Official Title  ICMJE Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early Stage Breast Cancer
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.

Detailed Description

OBJECTIVES:

Primary

  • 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

  • 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; the evaluations at 12 and 24 weeks are to determine the benefit of additional 6 weekly acupuncture treatments for maintenance and to determine the durability of response after stopping acupuncture, respectively; the evaluation at 52 weeks is to determine the long-term effects of acupuncture and adherence to AIs.
  • 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.
  • 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.
  • 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.
  • To evaluate the effects of acupuncture on the PROMIS Pain Impact-Short Form (PROMIS PI-SF) at 6, 12, 24, and 52 weeks.
  • 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.
  • 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.
  • To evaluate the effects of acupuncture on analgesic and opioid use at 2, 4, 6, 12, 16, 20, 24, and 52 weeks.
  • To evaluate the effects of acupuncture on self-reported AI adherence at 12, 24, and 52 weeks.
  • To assess AI adherence via urine AI metabolites at baseline, 24, and 52 weeks.
  • To evaluate the effects of acupuncture on serum hormones (estradiol, FSH, LH) and inflammatory biomarkers (serum TNFα, IL-6, IL-12, CRP, and urine c-telopeptides of Type II collagen (CTX-II) at 6, 12, and 24 weeks. (Exploratory)
  • To evaluate whether polymorphisms in CYP19A1 aromatase gene predict severity of AI-related joint symptoms. (Exploratory)
  • To assess the safety and tolerability of acupuncture in this study population.

OUTLINE: This is a multicenter study. Patients are stratified according to study site. 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. Patients complete the Brief Pain Inventory-Short Form (BPI-SF), the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the PROMIS Pain Impact-Short Form (PROMIS PI-SF), the FACT-ES Trial Outcome Index, and the Aromatase Inhibitor Usage Form questionnaires at baseline and at 6, 12, 24 and 52 weeks.

Patients undergo blood sample collection at baseline and at 6, 12, and 24 weeks for serum hormones (estradiol, FSH, LH) levels, inflammatory markers (TNFα, IL-6, IL-12, CRP), and DNA analysis. Urine samples are also collected at baseline and at 24 and 52 weeks for c-telopeptides of Type II collagen and aromatase inhibitor metabolites analysis.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Pain
Intervention  ICMJE
  • Procedure: acupuncture therapy
    Receive acupuncture
  • Procedure: sham acupuncture
    Receive sham acupuncture
Study Arms  ICMJE
  • Experimental: Arm I
    Patients receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
    Intervention: Procedure: acupuncture therapy
  • Sham Comparator: Arm II
    Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
    Intervention: Procedure: sham acupuncture
  • No Intervention: Arm III
    Patients are assigned to a waiting list for 12 weeks with standard follow-up care.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2018)
226
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2012)
228
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date June 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01535066
Other Study ID Numbers  ICMJE S1200
S1200 ( Other Identifier: SWOG )
R01AT000636-01 ( U.S. NIH Grant/Contract )
U10CA037429 ( U.S. NIH Grant/Contract )
NCI-2012-00251 ( Other Identifier: NCI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Southwest Oncology Group
Study Sponsor  ICMJE Southwest Oncology Group
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
PRS Account Southwest Oncology Group
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP