- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05121558
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy) (YCT)
A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
Rockville Centre, New York, United States, 11553
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga
Participants will receive twice weekly yoga over the course of 8 weeks.
|
Participants will have instructional yoga classes twice each week over the course of 8 weeks.
Each yoga class will be 60 minutes, and it will be taught by an experienced yoga instructor.
Participants will be provided with a home-based guided program for days classes are not held.
Participants in the yoga group will also have the option to participate in a recorded final check-in session after they have completed their 16 yoga classes.
The discussion facilitator will follow the Semi-Structured Interview Guide to further understand participants' experiences in the yoga group.
|
|
Experimental: Education control (EC)
Participants will receive twice weekly education over the course of 8 weeks
|
Participants will have educational sessions over 8 weeks.
The sessions will be on the causes and impact of Chemotherapy-Induced Peripheral Neuropathy (CIPN), how yoga may help with CIPN, and how different therapies may help with CIPN.
To encourage participation and adherence, patients in the EC group will receive sixteen free yoga sessions after completing the study.
Patients in the EC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.
|
|
Active Comparator: Usual care (UC)
8 weeks of usual care
|
Participants in the usual care control group will complete the same assessments as the other two arms.
To encourage participation and adherence, patients in the UC group will receive sixteen free yoga sessions after completing the study.
Patients in the UC group will be asked to not go for their own yoga classes locally until their participation in the study is completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga
Time Frame: 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").
|
up to 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ting Bao, MD, Dana-Farber Cancer Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Chronic Pain
- Neuralgia
- Agnosia
- Neuropathy, Painful
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Yoga
Other Study ID Numbers
- 23-517
- R01CA251470 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
noiVita SrlsUniversity of Eastern PiedmontCompletedCervical Pain | Pain Management | Lumbar Pain | Muscular | Chronic Pain (Back / Neck)Italy
-
Chinese University of Hong KongNot yet recruitingPain, Acute | Chronic Post Operative Pain | Pain, ChronicHong Kong
-
University of SaskatchewanRoyal University Hospital FoundationCompletedPain | Pain, Acute | Pain, Chronic | Pain, IntractableCanada
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on Yoga
-
Universität Duisburg-EssenCompleted
-
Ataturk UniversityKTO Karatay UniversityRecruiting
-
Adiyaman University Research HospitalCompletedDepression | Stress | Anxiety | Psychological ResilienceTurkey
-
NMP Medical Research InstituteYog-Kulam; Department of Zoology, University of Rajasthan, IndiaCompleted
-
NMP Medical Research InstituteWarwick Research Services; Yog-KulamCompleted
-
Northwestern UniversityCompleted
-
University of MinnesotaCompleted
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedDepression | Pain | Breast Cancer | FatigueUnited States
-
Saglik Bilimleri UniversitesiThe Scientific and Technological Research Council of TurkeyCompletedStress | Anxiety | Telerehabilitation | Yoga | University StudentsTurkey
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedProstate CarcinomaUnited States