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

Not Applicable

Recruiting

• Conditions: Chemotherapy-induced Peripheral Neuropathy; Nerve Pain; Neuropathy; Neuropathy, Painful; Pain; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Chronic Pain
• Interventions: Other: Education control; Other: Yoga; Other: Usual care

• Registration Number: NCT05121558
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-29
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-04
• Study First Posted: 2021-11-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education control (EC)	Education control	Participants will receive twice weekly education over the course of 8 weeks
Yoga	Yoga	Participants will receive twice weekly yoga over the course of 8 weeks.
Usual care (UC)	Usual care	8 weeks of usual care

Primary Outcome Measures

Name	Time	Method
measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga	up to 24 weeks	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").

Trial Locations

Locations (8)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Rockville Centre, New York, United States