Trial record 1 of 1 for:    s1200
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Southwest Oncology Group
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01535066
First received: February 14, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Pain
Procedure: acupuncture therapy
Procedure: sham acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women With Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Decrease of joint pain associated with the use of AIs as measured by BPI-SF [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Durability of response as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 52 weeks. ] [ Designated as safety issue: No ]
  • Long-term effects of acupuncture as assessed by BPI-SF, WOMAC, M-SACRAH, PROMIS PI-SF, FACT-ES, and TGUG [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Analgesic and opioid use [ Time Frame: 2, 4, 6, 12, 16, 20, 24, and 52 weeks ] [ Designated as safety issue: No ]
  • AI adherence [ Time Frame: 12, 24, and 52 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of acupuncture [ Time Frame: 2, 4, 6, 12, 16, 20, 24, and 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 228
Study Start Date: March 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive acupuncture therapy twice weekly for 6 weeks and then once weekly for 6 weeks.
Procedure: acupuncture therapy
Receive acupuncture
Sham Comparator: Arm II
Patients receive sham acupuncture twice weekly for 6 weeks and then once weekly for 6 weeks.
Procedure: sham acupuncture
Receive sham acupuncture
No Intervention: Arm III
Patients are assigned to a waiting list for 12 weeks with standard follow-up care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535066

Contacts
Contact: Kimberly Kaberle 2106148808 ext 1022 kkaberle@swog.org
Contact: Dana Sparks, MAT 21-6148808 ext 1004 dsparks@swog.org

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033-0804
Contact: Debasish Tripathy    323-865-0451      
Principal Investigator: Debasish Tripathy         
Kaiser Permanente-Vallejo Recruiting
Vallejo, California, United States, 94589
Contact: Louis Fehrenbacher    626-564-3455      
Principal Investigator: Louis Fehrenbacher         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Paul G. Montgomery    800-845-4624      
Principal Investigator: Paul G. Montgomery         
Saint Luke's Mountain States Tumor Institute - Meridian Recruiting
Meridian, Idaho, United States, 83642
Contact: Paul G. Montgomery    800-845-4624      
Principal Investigator: Paul G. Montgomery         
United States, Michigan
Bronson Battle Creek Recruiting
Battle Creek, Michigan, United States, 49017
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Mecosta County Medical Center Recruiting
Big Rapids, Michigan, United States, 49307
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Grand Rapids Clinical Oncology Program Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Saint Mary's Health Care Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Spectrum Health at Butterworth Campus Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
Contact: Gilbert D. Padula    616-685-5225      
Principal Investigator: Gilbert D. Padula         
United States, New York
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
United States, Oregon
Legacy Good Samaritan Hospital and Medical Center Recruiting
Portland, Oregon, United States, 97210
Contact: Jacqueline Vuky    503-299-6500      
Principal Investigator: Jacqueline Vuky         
United States, South Carolina
Greenville CCOP Recruiting
Greenville, South Carolina, United States, 29615
Contact: Mark A. O'Rourke    864-241-6251      
Principal Investigator: Mark A. O'Rourke         
United States, Texas
Southwest Oncology Group Recruiting
San Antonio, Texas, United States, 78245
Contact: Dawn L. Hershman    734-998-7191    bakerl@med.umich.edu   
Principal Investigator: Dawn L. Hershman         
United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Anna C. Beck    801-581-4477    clinical.trials@hci.utah.edu   
Principal Investigator: Anna C. Beck         
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Julie R. Gralow    800-804-8824      
Principal Investigator: Julie R. Gralow         
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01535066     History of Changes
Other Study ID Numbers: S1200, S1200, R01AT000636-01, U10CA037429, NCI-2012-00251
Study First Received: February 14, 2012
Last Updated: April 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014