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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01612728
Recruitment Status : Withdrawn (The grant application for this project was rejected.)
First Posted : June 6, 2012
Last Update Posted : February 12, 2013
Information provided by (Responsible Party):
Baylor Breast Care Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Arthralgia Joint Pain Other: Women without Arthralgia Drug: Women with Arthralgia Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aromatase Inhibitor-Induced Arthralgia: A Proposed Management Algorithm
Study Start Date : October 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Women with Arthralgia
Women who develop joint pain on Aromatase Inhibitor therapy will be placed on the clinical algorithm, as specified in the protocol.
Drug: Women with Arthralgia
Other Name: Aromatase Inhibitor
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.
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01612728

Sponsors and Collaborators
Baylor Breast Care Center
Principal Investigator: Polly Niravath, MD Baylor College of Medicine

Responsible Party: Baylor Breast Care Center Identifier: NCT01612728     History of Changes
Other Study ID Numbers: AIA-001
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Baylor Breast Care Center:
Aromatase Inhibitors

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs