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

Last updated: December 6, 2024
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain (Pediatric)

Neurologic Disorders

Treatment

Yoga

Education control

Usual care

Clinical Study ID

NCT05121558
23-517
R01CA251470
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thepresence of symmetrical stocking-glove pain, numbness, or paresthesia Grade ≥1sensory 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 onthe BPI-SF average pain item over the past week

  • On a stable regimen (no change in three months) if taking anti-neuropathy or otherpain medications and not taking acetyl-L-carnitine 77

  • Willing to adhere to requirement that no new pain medication be taken throughout thefirst 12 weeks of the study period

  • Willing to adhere to all study-related procedures, including randomization to one ofthe three arms

  • Patient answers "Yes" to at least one factor in the question: "Do you think yourbalance, gait, posture, alignment, or flexibility has been affected by yourexperience of CIPN?"

Exclusion

Exclusion Criteria:

  • Patients who have received physical therapy or practiced yoga for CIPN in the past 3months. As patients who have received physical therapy or practiced yoga in thistime period may already be experiencing its benefits, we will exclude such patients.

Study Design

Total Participants: 268
Treatment Group(s): 3
Primary Treatment: Yoga
Phase:
Study Start date:
October 29, 2021
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Memoral Sloan Kettering Basking Ridge (Limited protocol activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited protocol activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Rockville Centre, New York 11553
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Rockville Centre, New York 11553
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.