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

NCT ID: NCT01612728

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-10-31

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 grip strength measurement) after institution of the algorithm. The investigators will also determine whether their compliance is improved compared to historical controls, and at least non-inferior to the women in the study who do not develop AIA. Finally, the investigators will measure serum estrogen level at baseline and then periodically during AI therapy to investigate whether more dramatic decline in estrogen level after initiation of an AI leads to significant AIA and earlier time to onset.

This study targets a very common cause of pain among breast cancer survivors and aims to offer an effective treatment strategy to alleviate pain and improve quality of life as well as medication compliance.

Conditions

Breast Cancer; Arthralgia; Joint Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Women with Arthralgia

Women who develop joint pain on Aromatase Inhibitor therapy will be placed on the clinical algorithm, as specified in the protocol.

Group Type: EXPERIMENTAL

Women with Arthralgia

Intervention Type: DRUG

Women without Arthralgia

Women who do not develop arthralgia will continue to have their joint pain and strength measured, as well as their medication compliance. However, they will not be placed on the clinical algorithm which is meant for alleviation of joint pains.

Group Type: OTHER

Women without Arthralgia

Intervention Type: OTHER

For mild arthralgia, women will try the following interventions in the following order: 1) Weight-bearing exercise program, and 2) Glucosamine \& Chondroitin supplements. For women with mild to moderate arthralgia, they will try to the following interventions in this order: 1) Acupuncture, 2) Indomethacin twice daily as needed, 3) Switch to a different aromatase inhibitor, and 4) Switch to tamoxifen.

Interventions

Women without Arthralgia

For mild arthralgia, women will try the following interventions in the following order: 1) Weight-bearing exercise program, and 2) Glucosamine \& Chondroitin supplements. For women with mild to moderate arthralgia, they will try to the following interventions in this order: 1) Acupuncture, 2) Indomethacin twice daily as needed, 3) Switch to a different aromatase inhibitor, and 4) Switch to tamoxifen.

Intervention Type: OTHER

Women with Arthralgia

Intervention Type: DRUG

Other Intervention Names

Aromatase Inhibitor

Eligibility Criteria

Inclusion Criteria

• age greater than 18 years
• stage I-III ER+ breast cancer
• beginning adjuvant AI therapy
• post-menopausal as defined by any of the following: age >60 years, history of bilateral oophorectomy, amenorrhea for 1 year with intact uterus and ovaries, or serum estradiol and FSH concentrations in the post-menopausal range along with either amenorrhea for 6 months or previous hysterectomy

Exclusion Criteria

• previous use of an aromatase inhibitor

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor Breast Care Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Polly Niravath, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Other Identifiers

AIA-001

Identifier Type: -

Identifier Source: org_study_id