Acupuncture and Aromatase Inhibitor Related Arthralgia

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

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.

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

• 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

Locations
United States
Pennsylvania
Abramson Cancer Center of The University of Pennsylvania
Philadelphia
Time Frame
Start Date: May 2009
Completion Date: April 21, 2016
Participants
Target number of participants: 76
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: Abramson Cancer Center of the University of Pennsylvania

This content was sourced from clinicaltrials.gov

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