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Completed

NCT Number: NCT00826397

Acupuncture for Aromatase Inhibitor Induced Joint Pain

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.

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Key information

Conditions

Breast Cancer Arthralgia Breast Diseases Breast Neoplasms Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

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

Sham acupuncture

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.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Pilot Study on the Effect of Acupuncture on Joint Pain Induced by Aromatase Inhibitors in Breast Cancer Patients

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jan 22, 2009
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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