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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 its benefits, we will exclude such patients.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05121558
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dana-Farber Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ting Bao, MD
Principal Investigator Affiliation	Dana-Farber Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Chronic Pain

Arms & Interventions

Arms

Experimental: Yoga

Participants will receive twice weekly yoga over the course of 8 weeks.

Experimental: Education control (EC)

Participants will receive twice weekly education over the course of 8 weeks

Active Comparator: Usual care (UC)

8 weeks of usual care

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115

Site Contact

Ting Bao, MD

[email protected]

857-215-2844

Basking Ridge, New Jersey

Status