Clinical trial NCT04042870: Effect of Sukshma Vyayama Yoga on Aromatase Inhibitor-Induced Arthralgia in Breast Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Yoga
Aromatase Inhibitor
Arthralgia
Sukshma Vyayama
Lead sponsor: AshtaYoga, LLC
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
name: Swami Vivekananda Yoga Anusandhana Samsthana
First posted: 2019-08-02
Enrollment: 38
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre / Post Single Control
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Patient-Reported Arthralgia Inventory (PRAI) Measure for Joint Arthralgia
timeFrame: Baseline and Four weeks
measure: Change in Brief Pain Inventory Short Form (BPI SF) Measure for Body Pain
timeFrame: Baseline and Four weeks
measure: Change in Brief Pain Inventory Short Form (BPI SF) Measure for Quality of Life
timeFrame: Baseline and Four weeks
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Measure for Pain, Stiffness, and Physical Function of Knee and Hip
timeFrame: Baseline and Four weeks
measure: Change in Disability of the Arm, Shoulder and Hand (DASH) Measure of Ability to Use Arm, Shoulder, and Hand
timeFrame: Baseline and Four weeks
Secondary outcomes:
measure: Effectiveness of Delivering Intervention on Facebook
timeFrame: Four Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Leigh Leibel, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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)