Randomized Trial of 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: February 19, 2013
Last verified: February 2013
  Purpose

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.

This is a randomized controlled pilot study, twenty participants will be recruited in each arm directly by their oncologist from the Breast Oncology clinic of Columbia University Medical Center. The study will include postmenopausal women over the age of 45 years, currently taking an aromatase inhibitor for the treatment of early stage breast cancer and experiencing musculoskeletal pain in one or more joints. We hypothesize that acupuncture will reduce AI induced joint symptoms


Condition Intervention Phase
Breast Cancer
Procedure: Acupuncture
Procedure: sham acupuncture
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Columbia University:

Primary Outcome Measures:
  • Reduction in joint pain as measured by BPI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in joint stiffness and function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Safety and tollerability [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
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 acupunture, 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:

This is aa 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 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 primary endpoint of this study is to compare the change in joint pain related to aromatase inhibitors in breast cancer patients treated with acupuncture and pharmacological therapy compared to pharmacological intervention alone before and after treatment. The primary efficacy endpoint will be a change in the Brief Pain Inventory-Short Form (BPI-SF) before and after treatment. Secondary objectives of this study include a change in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, dosage of analgesics (acetaminophen, NSAIDs or selective COX-2 inhibitors) consumed, quality of life as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B), blood levels of IL and TNF, frequency and severity of adverse events according to the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0, and assessment of attitudes towards complementary and alternative medicine.

The primary hypothesis is that acupuncture in conjunction with pharmacological treatment will decrease joint pain related to the use of aromatase inhibitors in breast cancer patients compared to pharmacological therapy alone. This hypothesis will be tested using logistic regression with acupuncture (yes/no) as the predictor and the change in the BPI-SF score after treatment (at six weeks) compared to baseline as the outcome. The logistic model will allow for the adjustment of possible confounders such as age, body mass index and years since menopause. Secondary outcomes include change in the WOMAC index, FACT-B quality-of-life measure, dosage of analgesics consumed, and blood levels of IL-and TNF after treatment compared to baseline. The change in all efficacy outcomes will be assessed in all patients (including those who have delayed cross-over to acupuncture) before and after acupuncture treatment. For the patients who receive immediate acupuncture treatment, all efficacy outcomes will be reassessed at twelve weeks to examine the duration of effect upon completion of acupuncture. All treatment-related adverse events will be reported for both treatment arms. For the secondary endpoints, the differences between baseline, six weeks and twelve weeks will be studied for each efficacy outcome measure using descriptive statistics and graphical tools. Correlations between the biologic markers of inflammation and the efficacy measures will be evaluated by tabular and graphical form.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders 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 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

No publications provided

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: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
aromatase inhibitors
joint pain
symptoms control

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
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 28, 2014