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Acupuncture for Aromatase Inhibitor Induced Joint Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dawn L. Hershman, Columbia University
ClinicalTrials.gov Identifier:
NCT00826397
First received: January 21, 2009
Last updated: June 15, 2017
Last verified: June 2017
  Purpose

This is a randomized, controlled, pilot study to determine the safety and efficacy of acupuncture as an adjunct to pharmacological treatment compared to pharmacological intervention alone for the treatment of musculoskeletal pain related to aromatase inhibitors (AI) in postmenopausal breast cancer patients. Twenty participants (20 in each arm) will be enrolled at the Breast Oncology clinic at Columbia University Medical Center (CUMC). Patients in the treatment arm will receive acupuncture administered twice weekly for six weeks and will be allowed to take pain medication as necessary. The control patients will initially receive pain medication alone, then will cross-over to the acupuncture arm after six weeks. The investigators hypothesize that acupuncture will reduce AI induced joint symptoms.

The study will enroll a total of 40 patients, half of whom will be randomized to one of the two arms to receive acupuncture plus pharmacological treatment (arm A) or pharmacological treatment alone (arm B). Joint pain will be assessed by the BPI-SF score at baseline and six weeks. All patients will have a baseline BPI worst pain item (#2) ≥3 points on a scale of 0-10.


Condition Intervention
Breast Cancer Procedure: Acupuncture Procedure: Sham Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Dawn L. Hershman, Columbia University:

Primary Outcome Measures:
  • Change in Joint Pain [ Time Frame: Baseline and 6 weeks ]
    This is defined as the difference in the Brief Pain Inventory - Short Form (BPI-SF) scale at six weeks versus baseline.


Secondary Outcome Measures:
  • Change in Joint Stiffness and Function [ Time Frame: Baseline and 6 weeks ]
    The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index Version 3.1 will be used and consists of 24 questions related to three subscales: pain (0-20), stiffness (0-8) and physical function (0-68).

  • Safety and Tolerability measured by Frequency of Adverse Events [ Time Frame: 6 weeks ]
    Reporting of the severity and frequency of adverse events (NCI Common Terminology Criteria Version 3.0) (40) related to the interventions will be conducted every two weeks during telephone interviews. All treatment-related adverse events will be reported for both treatment arms.


Enrollment: 40
Actual Study Start Date: June 2005
Study Completion Date: September 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture Arm
Patients in the treatment arm will receive acupuncture administered twice weekly for six weeks and will be allowed to take pain medication as necessary.
Procedure: Acupuncture
Each acupuncture session will last approximately 45 minutes and includes standardized body treatment with an emphasis on affected joints.
Sham Comparator: Control Arm
The control patients will receive a form of sham acupuncture, which will consist of superficial needling at nonspecific body points, administered twice weekly for six weeks.
Procedure: Sham Acupuncture
The sham acupuncture session will consist of superficial needling at nonspecific body points, administered twice weekly for six weeks, and will last approximately 45 minutes and includes standardized body treatment with an emphasis on affected joints.

Detailed Description:

The purpose of this study is to determine the safety and efficacy of acupuncture as a complementary therapy to pain medication for joint pain associated with aromatase inhibitors for breast cancer treatment. Breast cancer patients are living longer largely due to the benefits of hormonal therapy. Aromatase inhibitors (AIs) are a new class of hormonal agents which block estrogen synthesis in postmenopausal women. However, musculoskeletal pain occurs in up to 50% of patients treated with AIs and often does not respond to conventional pain medications. AI-induced joint pain interferes with patient compliance and may cause major disability. Therefore, safe and effective treatments are needed to alleviate AI-induced musculoskeletal pain.

Acupuncture is a traditional Chinese method of medical treatment and a popular modality for treating musculoskeletal pain. Acupuncture involves the use of thin needles to stimulate specific points of the body and leads to pain control through the release of endorphin in the central nervous system. Clinical trials have found a benefit of acupuncture for the treatment of knee and back pain. Given the lack of effective treatments for AI-induced joint pain and the safety and efficacy of acupuncture, it is therefore reasonable to evaluate whether acupuncture is effective in breast cancer patients who experience musculoskeletal pain related to AIs.

  Eligibility

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Age>45 years
  • Postmenopausal status defined as cessation of menses for >1 year or follicle- stimulating hormone (FSH)>20 mIU/mL
  • History of stage I or II, hormone receptor-positive breast cancer
  • Currently taking a third-generation aromatase inhibitor (anastrazole, letrozole or exemestane)
  • Ongoing musculoskeletal pain in one or more joints (baseline BPI worst pain score > 3 points on a scale of 0 to 10)
  • English-speaking
  • Signed informed consent

EXCLUSION CRITERIA:

  • Previous treatment with acupuncture
  • Inflammatory, metabolic or neuropathic arthropathies
  • Bone fracture or surgery of the afflicted extremity during the past six months
  • Current narcotic use, corticosteroid therapy or cortisone injections
  • Severe concomitant illnesses or metastatic disease
  • Severe coagulopathy or bleeding disorder
  • Dermatological disease within the acupuncture area
  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: NCT00826397

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Dawn Hershman, MD Columbia University
  More Information

Responsible Party: Dawn L. Hershman, Associate Professor of Medicine & Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00826397     History of Changes
Other Study ID Numbers: AAAB2299
Study First Received: January 21, 2009
Last Updated: June 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn L. Hershman, Columbia University:
Aromatase Inhibitors
Joint Pain
Symptoms Control
Acupuncture

Additional relevant MeSH terms:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017