The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Primary Purpose
Chemotherapy-Induced Peripheral Neuropathy
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Yoga
Education control
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-Induced Peripheral Neuropathy focused on measuring Yoga, Nerve pain, 21-096
Eligibility 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 the benefits of yoga/stretching therapy, we will exclude such patients.
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Yoga
Education control (EC)
Usual care (UC)
Arm Description
Participants will receive twice weekly yoga over the course of 8 weeks.
Participants will receive twice weekly education over the course of 8 weeks
8 weeks of usual care
Outcomes
Primary Outcome Measures
measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga
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").
Secondary Outcome Measures
Full Information
NCT ID
NCT05121558
First Posted
November 4, 2021
Last Updated
October 11, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05121558
Brief Title
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
Official Title
A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Peripheral Neuropathy
Keywords
Yoga, Nerve pain, 21-096
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.
Masking
Care ProviderInvestigator
Masking Description
The PI and investigators, will be blinded to the patient's group assignment.
Allocation
Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Description
Participants will receive twice weekly yoga over the course of 8 weeks.
Arm Title
Education control (EC)
Arm Type
Experimental
Arm Description
Participants will receive twice weekly education over the course of 8 weeks
Arm Title
Usual care (UC)
Arm Type
Active Comparator
Arm Description
8 weeks of usual care
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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 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.
Intervention Type
Other
Intervention Name(s)
Education control
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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 a voucher for 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.
Primary Outcome Measure Information:
Title
measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga
Description
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").
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 the benefits of yoga/stretching therapy, we will exclude such patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
Email
maoj@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Wanqing Zhi, MD, PhD
Phone
631-623-4246
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
Facility Name
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD,MSCE
Phone
646-888-0866
First Name & Middle Initial & Last Name & Degree
Wanqing Zhi, MD, PhD
Phone
631-623-4246
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-888-0866
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
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