Yoga's impact on nerve pain from chemotherapy
A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)
This study is testing if yoga can help people with nerve pain from chemotherapy feel better compared to educational sessions or standard medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 268 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Boston, Massachusetts and 7 other locations) |
| Trial ID | NCT05121558 on ClinicalTrials.gov |
What this trial studies
This study investigates whether yoga can alleviate nerve pain caused by chemotherapy-induced peripheral neuropathy (CIPN). Participants will be assigned to one of three groups: yoga classes, educational sessions about CIPN and its management, or standard care with medications. The study will assess the effects of these interventions on balance, fall risk, and quality of life, as well as the impact of yoga on sensory deficits associated with CIPN. Functional assessments will be conducted both virtually and in-person to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates include English-proficient adults aged 18 and older who have completed neurotoxic chemotherapy and experience moderate to severe CIPN pain.
Not a fit: Patients currently undergoing chemotherapy or those with uncontrolled oncologic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological approach to managing nerve pain for cancer survivors.
How similar studies have performed: Other studies have shown promising results for yoga in managing chronic pain, suggesting potential success for this approach in CIPN.
Eligibility criteria
Show full 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.
Where this trial is running
Boston, Massachusetts and 7 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ting Bao, MD — Dana-Farber Cancer Institute
- Study coordinator: Ting Bao, MD
- Email: ting_bao@dfci.harvard.edu
- Phone: (857) 215-2844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.