Chemotherapy-induced Peripheral NeuropathyYCTNCT05121558
The Effect of Yoga on Nerve Pain Caused by Chemotherapy (Chemotherapy-Induced Peripheral Neuropathy)
A study testing Yoga in people with Chemotherapy-induced Peripheral Neuropathy and Nerve Pain, run by Dana-Farber Cancer Institute at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Oct 2021to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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?"
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553
About this study
Official title: 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
Read more
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.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Being tested
- Yoga, Education control, Usual care
- Keywords
- Yoga, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain, Pain Management, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Cancer survivor, CIPN
- Medical subject headings
- Neuralgia, Neuropathy, Painful, Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
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.
Education controlOther
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.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Participants will receive twice weekly yoga over the course of 8 weeks. Receives: Other: Yoga |
| Education control (EC) | Experimental | Participants will receive twice weekly education over the course of 8 weeks Receives: Other: Education control |
| Usual care (UC) | Active comparator | 8 weeks of usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start29 Oct 2021
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute
- Investigators
- Weidong Lu, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121558
- Sponsor's protocol ID
- 23-517
- Other IDs
- R01CA251470
- Acronym
- YCT
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Clinical Trial of Yoga for Chemotherapy-induced Peripheral Neuropathy Treatment (YCT)
- ClinicalTrials.gov ID
- NCT05121558
- Acronym / sponsor ID
- YCT / 23-517
- Conditions
- Chemotherapy-induced Peripheral Neuropathy, Nerve Pain, Neuropathy, Neuropathy, Painful, Pain, CIPN - Chemotherapy-Induced Peripheral Neuropathy
- Keywords
- Yoga, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain, Pain Management, Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Cancer survivor, CIPN
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- Model description
- 3-arm parallel randomized controlled trial (RCT) comparing yoga to a non-physical education control (EC) and usual care.
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaParticipants will receive twice weekly yoga over the course of 8 weeks. |
| Education control (EC) | Experimental | Other: Education controlParticipants will receive twice weekly education over the course of 8 weeks |
| Usual care (UC) | Active comparator | Other: Usual care8 weeks of usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaParticipants 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. | Other | Yoga |
| Education controlParticipants 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. | Other | Education control (EC) |
| Usual careParticipants 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. | Other | Usual care (UC) |
Primary outcome
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").
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Chemotherapy-induced Peripheral Neuropathy
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
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RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Lu, MD principal investigator
Dana-Farber Cancer Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Chemotherapy-induced Peripheral Neuropathy and Nerve Pain, run by Dana-Farber Cancer Institute at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.