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

Breast Cancer Clinical Trial

— AIA  

Official title:

Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01612728
• Other study ID #: AIA-001
• Status: Withdrawn
• Phase: Phase 2
• First received: June 4, 2012
• Last updated: February 11, 2013
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: February 2013
• Source: Baylor Breast Care Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Joint Pain

Intervention

Other:
• 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.

Drug:
• Women with Arthralgia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Breast Care Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication compliance	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.	9 months	No
Secondary	improvement of AIA symptoms with use of the algorithm	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.	9 months	No