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

Breast Cancer Clinical Trial

Official title:

Effect of Sukshma Vyayama Joint Loosening Yoga on Aromatase Inhibitor-Induced Arthralgia in Post-Menopausal Breast Cancer Survivors: A Feasibility Study Conducted on Facebook

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042870
• Other study ID #: AI Yoga Study on Facebook - 1
• Status: Completed
• Phase: N/A
• Start date: September 4, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: August 2019
• Source: AshtaYoga, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 19, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
AshtaYoga, LLC	Columbia University, Swami Vivekananda Yoga Anusandhana Samsthana

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia	The Patient-Reported Arthralgia Inventory measures self-reported pain intensity in 16 specific joints over the past 7 days. This questionnaire consists of 16 questions answered on a 0 to 10 scale (0 = no pain at all; 10 = worst pain you can imagine) with a min of 0 and a max of 160. Higher scores indicate more pain.	Baseline and Four weeks
Primary	Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain	The Brief Pain Inventory Short Form measures self-reported pain intensity in the body in the last 24-hours. This questionnaire consists of 8 questions (4 on pain quality) answered on a scale 0-10 (0 = no pain; 10 = pain as bad as you can imagine) with a min of 0 and a max of 40. Higher scores indicate more pain.	Baseline and Four weeks
Primary	Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life	The Brief Pain Inventory Short Form measures self-reported QoL in the last 24-hours. This questionnaire consists of 7 questions answered on a scale 0-10 (0 = does not interfere; 10 = completely interferes) with a min of 0 and a max of 70. Higher scores indicate lower QoL.	Baseline and Four weeks
Primary	Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip	The Western Ontario and McMaster Universities Osteoarthritis Index measures self-reported pain, stiffness, and functional limitation of knee and hip during activity in the last 48-hours. This questionnaire consists of 24 questions answered on a scale 0-4 (0 = none; 4 = extreme). Measures include five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate greater pain, stiffness, and functional limitation.	Baseline and Four weeks
Primary	Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand	The Disability of the Arm, Shoulder and Hand tool measures self-reported ability to do daily activities in the last week and impact on QoL. The questionnaire consists of 30 questions answered on a scale 1-5 (1 = no difficulty; 5 = unable) with a min of 30 and a max of 150. Measures include 21 items for daily functional activity (score range 30-105), two for interference with social or work activity (score range 2-10), five for pain and discomfort (score range 5-25), one for sleep (score range 1-5), and one for confidence (score range 1-5). Higher scores indicate greater pain and disability.	Baseline and Four weeks
Secondary	Effectiveness of Delivering Intervention on Facebook	Measure whether sufficient numbers of subjects enroll in order to complete the study.	Four Weeks