Acupuncture for Aromatase Inhibitor Induced Joint Pain

NCT00826397 | Completed

• 1 other identifier: AAAB2299
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Aromatase Inhibitors; Joint Pain; Symptoms Control; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Change in Joint Pain

  This is defined as the difference in the Brief Pain Inventory - Short Form (BPI-SF) scale at six weeks versus baseline.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Change in Joint Stiffness and Function

  Baseline and 6 weeks

• Safety and Tolerability measured by Frequency of Adverse Events

  6 weeks

Study Arms (2)

Acupuncture Arm

EXPERIMENTAL

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

Control Arm

SHAM COMPARATOR

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

Interventions

Acupuncture PROCEDURE

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

Acupuncture Arm

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.

Control Arm

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Dawn Hershman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine & Epidemiology

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: June 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: September 1, 2009
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

US (1)