Breast Cancer Clinical Trial

Tai Chi for Relieving Aromatase Inhibitor-Induced Arthralgia in Patients With Stage I-III Breast Cancer, the TaiChi4Joint Trial

Summary

This trial studies new methods using Tai Chi for the relief of joint pain (arthralgia) caused by an aromatase inhibitor in patients with stage I-III breast cancer. Tai Chi is a mind-body therapy that integrates moderate physical activity, deep breathing and meditation. Tai Chi may help to reduce aromatase inhibitor-induced joint pain, and offer a promising approach to managing symptoms in cancer patients.

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Full Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility, acceptability, and preliminary efficacy of a 12-week Tai Chi intervention for relieving aromatase inhibitor (AI)-induced arthralgia in women with breast cancer (BCa).

OUTLINE:

Patients attend Tai Chi exercise classes over 1 hour twice weekly (BIW) and wear a Fitbit device for up to 12 weeks. Patients are encouraged to complete self-practice over 30 minutes and record practice times daily in a diary log form. Patients also join a Facebook private TaiChi4joint group where they receive instructional videos matching the progress of weekly classes for at-home practices and peer support in Tai Chi engagement.

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Eligibility Criteria

Inclusion Criteria:

Be able to speak and read English
Been diagnosed with stage I-III breast cancer (BC)
Had completed all active treatments
Had been receiving an AI (anastrozole, letrozole, or exemestane) for at least 3 months
Had joint (knee, hand or hip) pain or stiffness that started or worsened after the initiation of AI
Report worst pain in the past week >= 4 on a 0-10 numeric rating scale
Be willing to adhere to all study procedures

Exclusion Criteria:

Has been diagnosed with another form of cancer in the past 5 years
Uncontrolled cardiac, pulmonary, or infectious disease
Body mass index (BMI) > 40 kg/m^2
Currently attending any mind-body therapy classes (e.g. yoga)
Joint pain due to inflammatory arthritic condition (such as rheumatoid arthritis, osteoarthritis or gout, which will be assessed during eligibility screening with patient self-reported data and will be screened through electronic medical record [EMR] data)
Had surgery or joint infection in the past 6 months
Currently taking corticosteroids or opioids, have discontinued or plan to discontinue AI in the next 6 months

Study is for people with:

Breast Cancer

Estimated Enrollment:

39

Study ID:

NCT04716920

Recruitment Status:

Completed

Sponsor:

Thomas Jefferson University

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There is 1 Location for this study

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Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

39

Study ID:

NCT04716920

Recruitment Status:

Completed

Sponsor:


Thomas Jefferson University

How clear is this clinincal trial information?

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