Acupuncture for Aromatase Inhibitor Induced Joint Pain

NCT ID: NCT00826397

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-09-30

Brief Summary

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.

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.

Conditions

Breast Cancer

Keywords

Aromatase Inhibitors; Joint Pain; Symptoms Control; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: PROCEDURE

Each acupuncture session will last approximately 45 minutes and includes standardized body treatment with an emphasis on affected joints.

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.

Group Type: SHAM_COMPARATOR

Sham Acupuncture

Intervention Type: PROCEDURE

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.

Interventions

Acupuncture

Each acupuncture session will last approximately 45 minutes and includes standardized body treatment with an emphasis on affected joints.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Dawn L. Hershman

Associate Professor of Medicine & Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn Hershman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

AAAB2299

Identifier Type: -

Identifier Source: org_study_id