Clinical Trial: Treatment for Joint Pains Due to Aromatase Inhibitor Therapy in Breast Cancer

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm

Brief Summary:

Aromatase inhibitors are the most effective adjuvant anti-hormonal therapy for estrogen receptor positive (ER+) post-menopausal breast cancer patients, with proven superiority over tamoxifen in terms of disease-free survival, time to recurrence, and contralateral breast cancer. However, approximately half of the women who take this drug will develop significant joint pains, termed Aromatase Inhibitor-Induced Arthralgia (AIA). Though this medicine should be taken for 5 years, the joint pain can be so troublesome that up to 13% may prematurely discontinue it because of the arthralgia, thus sacrificing their best chance of recurrence-free survival. Nonetheless, neither the etiology nor optimal management of AIA is clearly understood, leaving both doctor and patient rather frustrated.

The investigators therefore propose to test the hypothesis that AIA can be effectively treated by a new clinical algorithm, and that effective treatment of the problem will lead to improved compliance with Aromatase Inhibitor (AI) therapy. The algorithm is a clinical pathway for treating AIA which incorporates, in a rational and step-wise manner, a series of interventions based on the available evidence. Interventions include acupuncture, pain medication, weight bearing exercise, and other commonly used therapies for AIA.

The investigators will enroll 100 women who are beginning adjuvant AI therapy and assess each woman's baseline joint pains via a questionnaire as well as grip strength measurement. The investigators will then periodically repeat these tests during AI therapy in order to systematically quantify and characterize AIA. Those women who develop AIA during the course of the study will be placed on the clinical algorithm, and the investigators will observe whether their joint pains significantly improve (as measured by questionnaire and

Detailed Summary:
Sponsor: Baylor Breast Care Center

Current Primary Outcome: Medication compliance [ Time Frame: 9 months ]

The primary objective of the study will be to estimate medication compliance among women with and without arthralgia with use of the proposed algorithm in those women with AIA.


Original Primary Outcome: Same as current

Current Secondary Outcome: improvement of AIA symptoms with use of the algorithm [ Time Frame: 9 months ]

The secondary objectives of the study will be correlation of the estrogen level with clinical development of arthralgia, as well as greater improvement of AIA symptoms with use of the algorithm.


Original Secondary Outcome: Same as current

Information By: Baylor Breast Care Center

Dates:
Date Received: June 4, 2012
Date Started: October 2013
Date Completion: October 2014
Last Updated: February 11, 2013
Last Verified: February 2013