The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

Study Overview
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Brief Summary
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The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN). Participants will take one of three approaches: Yoga classes Educational sessions on the causes and impacts of CIPN, how yoga may help with CIPN, and how different therapies may help with CIPN Usual care with standard-of-care medications for CIPN The researchers will compare how these different approaches affect participants' balance, their risk of falls, and their quality of life. This study will also measure how much yoga can help the reduced sense of touch caused by CIPN. The functional assessments TUG and CTS can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment FRT and QST assessments that can only be completed in-person are optional at these time points.

Official Title
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A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)

Conditions
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Chemotherapy-Induced Peripheral Neuropathy

Intervention / Treatment
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* Other: Yoga
* Other: Education control
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-proficient men and women aged ≥18 years Free of oncologic disease or or stable disease by clinical examination and history Completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months prior to enrollment Diagnosis of CIPN based on symptom history, loss of deep tendon reflexes, or the presence of symmetrical stocking-glove pain, numbness, or paresthesia Grade ≥1 sensory pain based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week On a stable regimen (no change in three months) if taking anti-neuropathy or other pain medications and not taking acetyl-L-carnitine 77 Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period Willing to adhere to all study-related procedures, including randomization to one of the three arms Patient answers Yes to at least one factor in the question: Do you think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN? Exclusion Criteria: Patients who have received physical therapy or practiced yoga for CIPN in the past 3 months. As patients who have received physical therapy or practiced yoga in this time period may already be experiencing the benefits of yoga/stretching therapy, we will exclude such patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Participants will receive twice weekly yoga over the course of 8 weeks. | Other: Yoga<br>* Participants will have instructional yoga classes twice each week over the course of 8 weeks. Each yoga class will be 60 minutes, and it will be taught by an experienced yoga instructor. Participants in the yoga group will also have the option to participate in a recorded final check-in session after they have completed their 16 yoga classes. The discussion facilitator will follow the Semi-Structured Interview Guide to further understand participants' experiences in the yoga group.<br>|
| Experimental: Education control (EC)<br>Participants will receive twice weekly education over the course of 8 weeks | Other: Education control<br>* Participants will have educational sessions over 8 weeks. The sessions will be on the causes and impact of Chemotherapy-Induced Peripheral Neuropathy (CIPN) , how yoga may help with CIPN, and how different therapies may help with CIPN.<br>|
| Active Comparator: Usual care (UC)<br>8 weeks of usual care | Other: Usual care<br>* Participants in the usual care control group will complete the same assessments as the other two arms. To encourage participation and adherence, patients in the UC group will receive a voucher for sixteen free yoga sessions after completing the study. Patients in the UC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga | as measured by the Brief Pain Inventory-Short Form (BPI-SF )compared to EC and UC arms at week 8 response choices of 0 (no pain) to 10 (pain as bad as you can imagine). | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Nerve pain, 21-096