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

Summary

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 Timed Up and Go (TUG) and Chair to Stand (CTS) can be safely completed either virtually and in-person and will be mandatory for all patients. The functional assessment Functional Reach Test (FRT) and Quantitative Sensory Testing (QST) assessments that can only be completed in-person are optional at these time points.

Conditions

• Chemotherapy-induced Peripheral Neuropathy
• Nerve Pain
• Neuropathy
• Neuropathy, Painful
• Pain
• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Chronic Pain

Interventions

OTHER

Yoga

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 will be provided with a home-based guided program for days classes are not held. 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.

OTHER

Education control

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. To encourage participation and adherence, patients in the EC group will receive sixteen free yoga sessions after completing the study. Patients in the EC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.

OTHER

Usual care

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 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Dana-Farber Cancer Institute

  lead OTHER

Principal Investigators

• Ting Bao, MD · Dana-Farber Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-29

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States

Study Locations