Acupuncture and Aromatase Inhibitor Related Arthralgia

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable

RATIONALE: Acupuncture may help relieve moderate or severe joint pain caused by aromatase inhibitors. PURPOSE: This randomized phase II trial is studying acupuncture in treating women with stage I, stage II, or stage III breast cancer with aromatase inhibitor-related joint pain.

Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No

• History of stage I, II, or III breast cancer

• Visit with oncologist within the previous 3-month period and free of disease by clinical examination and history

• Currently receiving aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) as per chart abstraction

• Postmenopausal, as defined by cessation of menses for a least 1 year or FSH > 40 mlU/mL

• Can understand written English

• Having worst joint pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week

• Having had at least 15 days with pain in the preceding 30 days

• Having had joint pain for at least 3 months

• Joint pain attributed to the use of aromatase inhibitors

• Willingness to adhere to all study-related procedures including randomization to one of the three possible choices: real acupuncture, placebo acupuncture, and wait-list control

United States
Abramson Cancer Center of The University of Pennsylvania
Time Frame
Start Date: May 2009
Completion Date: April 21, 2016
Target number of participants: 76
Experimental: Arm I (Acupuncture)
Patients undergo 10, 20-minute sessions of acupuncture over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments).
Sham Comparator: Arm II (Placebo)
Patients undergo 10, 20-minute sessions of sham acupuncture treatments over 8 weeks (twice weekly for 2 weeks and 6 weekly treatments) via Streitberger needles at non-acupuncture points.
No Intervention: Arm III (Control)
Wait-list control patients are contacted by phone at the same frequency as real and placebo acupuncture groups for data collection at weeks 1, 4, and 8.
Related Therapeutic Areas
Leads: Abramson Cancer Center of the University of Pennsylvania

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