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NCT05121558 | RECRUITING | Chemotherapy-induced Peripheral Neuropathy

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

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Ting Bao, MD

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.

Condition or disease

Chemotherapy-induced Peripheral Neuropathy

Nerve Pain

Neuropathy

Neuropathy, Painful

Pain

CIPN - Chemotherapy-Induced Peripheral Neuropathy

Chronic Pain

Intervention/treatment

Yoga

Education control

Usual care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 268 participants
Masking : DOUBLE
Masking Description : The PI and investigators, will be blinded to the patient's group assignment.
Primary Purpose : TREATMENT
Official Title : A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)
Actual Study Start Date : 2021-10-29
Estimated Primary Completion Date : 2025-10-01
Estimated Study Completion Date : 2025-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)

Location Details

NCT05121558

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Locations

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02115

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Center, New York, United States, 11553