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

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Nerve Pain; Chemotherapy-induced Peripheral Neuropathy; CIPN - Chemotherapy-Induced Peripheral Neuropathy; Chronic Pain; Neuropathy, Painful; Neuropathy; Pain

Treatments: Other: Education control; Other: Yoga; Other: Usual care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05121558

23-517

R01CA251470 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 227 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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227 participants in 3 patient groups

Yoga

Experimental group

Description:

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

Treatment:

Other: Yoga

Education control (EC)

Experimental group

Description:

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

Treatment:

Other: Education control

Usual care (UC)

Active Comparator group

Description:

8 weeks of usual care

Treatment:

Other: Usual care