Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors

NCT ID: NCT04042870

Last Updated: 2019-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2018-10-19

Brief Summary

The purpose of this study is to investigate the efficacy of sukshma vyayama joint loosening yoga in improving aromatase inhibitor-induced arthralgia in post-menopausal breast cancer survivors and secondarily, to evaluate the feasibility of delivering the intervention on Facebook.

Detailed Description

Cancer survival rates are improving in the United States but this increased survivorship is offset by persistent treatment related symptoms, particularly for post-menopausal breast cancer survivors treated with aromatase inhibitor (AI) hormonal therapy. AI therapy is well known to cause arthralgia that can compromise a woman's quality of life. National Comprehensive Cancer Center Network (NCCCN) guidelines for breast cancer treatment recommend that post-menopausal women with estrogen receptor-positive tumors receive aromatase inhibitors, e.g., anastrozole (Arimidex), letrozole (Femara) or exemestane (Aromasin) as a key part of treatment to lower the risk of breast cancer recurrence, breast cancer in the opposite breast, and death from breast cancer. Estrogen receptor-positive breast cancer represents almost 50% of all newly diagnosed cases of breast cancer. Currently, AIs are prescribed for five to ten years. The length of this treatment, coupled with difficult arthritic side effects can make it difficult for patients to complete therapy. Arthralgia occurs in up to 50% of breast cancer survivors treated with AIs and is the most common reason for poor AI adherence. Up to 50% of patients do not take AIs as prescribed and up to 20% will become non-compliant with treatment within the first year due to pain and discomfort. To get the most benefit out of hormone therapy, however, patients must take the full course of treatment. Both non-adherence and early discontinuation of AIs have been shown to be independent predictors of mortality. Women who complete the full course have better survival than those who do not. Given the efficacy of AIs in preventing breast cancer recurrence, and the proportion of women who discontinue these drugs because of adverse events, interventions to improve adverse effects are important.

This study investigated the efficacy of sukshma vyayama joint loosening yoga in reducing and improving aromatase inhibitor-induced joint pain and achiness in post-menopausal breast cancer patients, and evaluated the feasibility of delivering the intervention on Facebook. Hypothesis: Given global disparities in healthcare, being able to safely deliver evidence-based yoga interventions via the internet is important.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Joint Loosening Yoga

Yoga Intervention. Dose: 15 minutes, M-F for 4-weeks.

Group Type: EXPERIMENTAL

Joint Loosening Yoga

Intervention Type: BEHAVIORAL

Sukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes.

Interventions

Joint Loosening Yoga

Sukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Postmenopausal breast cancer survivors undergoing treatment with aromatase inhibitor hormonal therapy with self-reported arthralgia
• Must have initiated anastrazole, exemestane, or letrozole within 30 days of baseline assessment
• 35-70 years old
• Must be available during the dates of the study and willing to participate in the study
• Must have access to computer, tablet or smart phone and Internet connection
• Must be a member of Facebook
• Eligible if their arthralgia started after initiation of an AI or if they had preexisting joint pain that was exacerbated by AI use
• English speaking

Exclusion Criteria

• Non English-speaking
• Physically unable to perform the intervention

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

Swami Vivekananda Yoga Anusandhana Samsthana

UNKNOWN

Sponsor Role: collaborator

AshtaYoga, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leigh Leibel, MSc

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Leibel L, Metri K, Prasad R, Mears JG, Effect of Sukshma Vyayama on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook, J Clin Oncol 37, 2019 (suppl; abstr e23129)

Reference Type: RESULT

Other Identifiers

AI Yoga Study on Facebook - 1

Identifier Type: -

Identifier Source: org_study_id