Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)

This research is being done to determine whether a 12-week virtual Tai Chi training program, designed to improve balance and small nerve fiber function, is feasible and acceptable among cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).

Study Overview

• Status: Recruiting
• Conditions: Neuropathy; Peripheral Neuropathies; Peripheral Neuropathy Due to Chemotherapy; Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Intervention / Treatment: Behavioral: Tai Chi Program

Detailed Description

This is a prospective, randomized, waitlist-controlled pilot trial to examine the suitability of the virtual Tai Chi program in cancer survivors with CIPN. Tai Chi is a mind-body practice that involves gentle body movements, meditation, and breathing techniques. It has proven to be effective in enhancing balance control and relieving musculoskeletal pains.

This study randomly assigns cancer survivors with CIPN with self-perceived balance difficulties to one of two groups: Group A Tai Chi Group versus Group B Waitlist Group. Randomization means a participant is placed into a study group by chance.

The research study procedures including screening for eligibility, questionnaires, and sensory and functional testing.

Participation in this study is expected to last for up to 12 weeks.

It is expected that about 21 people will take part in this research study.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Bao, MD; Phone Number: 857-215-2844; Email: ting_bao@dfci.harvard.edu
• Study Contact Backup: Name: Natalie Viyaran; Email: natalie_viyaran@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Ting Bao, MD; Phone Number: 857-215-2844; Email: ting_bao@dfci.harvard.edu
      • Principal Investigator: Ting Bao, MD
      • Contact: Peter Wayne, PhD; Phone Number: 617-732-6271; Email: pwayne@bwh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years old and older
• Cancer survivors with no evidence of disease (cancer);
• Completed neurotoxic chemotherapy, i.e., platinum agents, taxanes, vinca alkaloids, and bortezomib, at least three months before enrollment;
• A CIPN diagnosis based on symptom history, loss of deep tendon reflexes, or presence of symmetrical stocking-glove pain, numbness, or paresthesia;
• Answers "yes" to the following question: "Do you feel as though your balance is affected from experiencing CIPN?" or "Are you afraid of falling as a result of your CIPN?";
• On a stable regimen (no change in past three months) if taking anti-neuropathy or other pain medications;
• Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤ 2
• Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, 2 in-person visits to Dana-Farber Cancer Institute (DFCI) (one within 2 weeks of enrollment and one at week 12);
• Willing to adhere to requirement that no new pain medication be taken throughout the study period; and
• Individuals receiving endocrine therapy or targeted/antibody therapy, such as trastuzumab, pertuzumab, or immunotherapy, will be eligible to participate.

Exclusion Criteria:

• Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Tai Chi Treatment Group; 14 randomized participants will complete: 1 baseline visit session.; Virtual Tai Chi session 2x weekly (60 minutes per session).; Independent Tai Chi sessions 3 days a week (60 minutes per session).; 12 week follow up visit.	Behavioral: Tai Chi Program; 12-week virtual Tai Chi program with experienced Tai Chi instructor. Sessions will be conducted via the HIPPA-compliant teleconference platform, Zoom.
No Intervention: Arm B: Waitlist Control Group; 7 randomized participants will complete: 1 baseline visit session; Standard CIPN care prescribed by primary care physician/oncologist.; 12 week follow up visit; Participants will be offered 24 complimentary, virtual, Tai Chi training sessions over 12 weeks after completion of the 12-week follow-up visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Rate for the Tai Chi Program	The intervention is considered feasible if 21 participants are enrolled within the first 6 months of the study period.	6 months
Assessment Completion Rate	The intervention is considered feasible if 75% of all evaluable participants, 16 out of 21, complete the biobehavioral assessments during the intervention period.	12 weeks
Session Completion Rate	The intervention is considered feasible if 62% of participants in the intervention arm, 9 out of 14, attend at least 80% or 20 of the 24 online sessions.	12 weeks
Acceptability of Intervention Measure (AIM) Score	Assessed by the Acceptability of the Intervention Measure (AIM), a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consent Rate (Arm A)	Defined as the proportion of participants enrolled out of those eligible for study entry.	Up to 6 months (based on total accrual duration)
Consent Rate (Arm B)	Defined as the proportion of participants enrolled out of those eligible for study entry.	Up to 6 months (based on total accrual duration)
Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A)	Assessed by the BBS, a 14-item tool to measure participant balance ability. Each task is scored on a scale from 0 to 4 with a total scores range of 0 to 56. A higher score indicates better balance.	Baseline and 12 weeks
Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm B)	Assessed by the BBS, a 14-item tool to measure participant balance ability. Each task is scored on a scale from 0 to 4 with a total scores range of 0 to 56. A higher score indicates better balance.	Baseline and 12 weeks
Change in Fall Rate from Baseline to 12 Weeks (Arm A)	Defined as the number of falls which occur during the intervention period. A fall is an unplanned descent to the floor with or without injury according to the National Database of Nursing Quality Indicators (NDNQI) definition. Falls included are 1) those occurring on a surface where caregivers and clinicians do not expect to find a participant, and 2) falls unassisted or assisted, and 3) falls from rolling off a low bed.	Baseline and 12 weeks
Change in Fall Rate from Baseline to 12 Weeks (Arm B)	Defined as the number of falls which occurred during the intervention period. A fall is an unplanned descent to the floor with or without injury according to the National Database of Nursing Quality Indicators (NDNQI) definition. Falls included are 1) those occurring on a surface where caregivers and clinicians do not expect to find a participant, and 2) falls unassisted or assisted, and 3) falls from rolling off a low bed.	Baseline and 12 weeks
Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A)	As defined by the NDNQI definitions for fall-related injuries. Injuries will be recorded by the participant in the supplied home diary and will be summarized descriptively.	Baseline and 12 weeks
Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B)	As defined by the NDNQI definitions for fall-related injuries. Injuries will be recorded by the participant in the supplied home diary and will be summarized descriptively.	Baseline and 12 weeks
Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A)	Assessed by the TUG Test. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back, and sit down. The test is timed in seconds, with a longer time indicating worse performance. Nine seconds is the cutoff for high risk of falls.	Baseline to 12 weeks
Change in TUG Test from Baseline to 12 Weeks (Arm B)	Assessed by the TUG Test. Participants are instructed to stand up from a chair, walk three meters as quickly and safely as possible, turn around, walk back, and sit down. The test is timed in seconds, with a longer time indicating worse performance. Nine seconds is the cutoff for high risk of falls.	Baseline to 12 weeks
Change in Brief Pain Inventory-Short For (BPI-SF) Score from Baseline to 12 Weeks (Arm A)	Assessed by the BPI-SF, 9-item measure of the severity of pain and pain interference in the 24 hours prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.	Baseline to 12 weeks
Change in BPI-SF Score from Baseline to 12 Weeks (Arm B)	Assessed by the BPI-SF, 9-item measure of the severity of pain and pain interference in the 24 hours prior to questionnaire administrations. A simple numeric rating scale from 0 to 10 is used for item rating, and a total score is the mean of the item ratings. Higher scores indicate greater pain intensity and greater interference with function.	Baseline to 12 weeks
Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm A)	Assessed by the Ntx Subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) questionnaire. The Ntx Subscale is an 11-item measure of symptoms in the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much" with a total scores range of 0 to 44. Higher scores represent higher functioning and fewer or less severe CIPN symptoms.	Baseline to 12 weeks
Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm B)	Assessed by the Ntx Subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG) questionnaire. The Ntx Subscale is an 11-item measure of symptoms in the 7 days prior to questionnaire administration. Answers are rated on a 5-point Likert scale ranging from 0 "Not at all" to 4 "Very much" with a total scores range of 0 to 44. Higher scores represent higher functioning and fewer or less severe CIPN symptoms.	Baseline and 12 weeks
Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm A)	This will be measured using a set of 20 Von Frey monofilaments. With participant's eyes closed, and starting at the smallest size filament, the clinical research coordinator (CRC) will touch the testing site at a 90-degree angle to the site surface until the filament bends for a one second duration. The CRC will continue this with ascending filament size in order until the participant reports feeling a touch sensation at the testing location. The force at which touch is perceived will be recorded as the tactile threshold. Tactile threshold will be assessed at the dorsum of the interphalangeal joint of the right and left big toes. Value will be recorded as the average of three readings.	Baseline and 12 weeks
Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm B)	This will be measured using a set of 20 Von Frey monofilaments. With participant's eyes closed, and starting at the smallest size filament, the clinical research coordinator (CRC) will touch the testing site at a 90-degree angle to the site surface until the filament bends for a one second duration. The CRC will continue this with ascending filament size in order until the participant reports feeling a touch sensation at the testing location. The force at which touch is perceived will be recorded as the tactile threshold. Tactile threshold will be assessed at the dorsum of the interphalangeal joint of the right and left big toes. Value will be recorded as the average of three readings.	Baseline and 12 weeks
Change in Vibration Threshold Value from Baseline to 12 weeks (Arm A)	This will be assessed using a handheld biothesiometer and the amplitude of vibration will be gradually increased (1 volt/second) until the sensation of vibration is first perceived by the participant. The average of three perception thresholds at the dorsal interphalangeal joint of the dominant big toe will be recorded as the vibration threshold.	Baseline to 12 weeks
Change in Vibration Threshold Value from Baseline to 12 weeks (Arm B)	This will be assessed using a handheld biothesiometer and the amplitude of vibration will be gradually increased (1 volt/second) until the sensation of vibration is first perceived by the participant. The average of three perception thresholds at the dorsal interphalangeal joint of the dominant big toe will be recorded as the vibration threshold.	Baseline to 12 weeks
Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm A)	Assessed by the Short FES-I, a 7-item measure of concerns about falls during daily activities. Answers are rated on a 4-point scale ranging from 1 "Not at all concerned" to 4 "Very concerned" with a total scores range of 7 to 28. A higher score represents greater participant concern.	Baseline to 12 weeks
Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm B)	Assessed by the Short FES-I, a 7-item measure of concerns about falls during daily activities. Answers are rated on a 4-point scale ranging from 1 "Not at all concerned" to 4 "Very concerned" with a total scores range of 7 to 28. A higher score represents greater participant concern.	Baseline to 12 weeks
Change in Functional Reach Test from Baseline to 12 Weeks (Arm A)	The FRT test is used to quantify balance ability. A participant is instructed to flex the test arm forward to 90 degrees and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point (with the handheld in a fist) to the point just before balance is lost. The final score is the average of three measurements.	Baseline to 12 weeks
Change in Functional Reach Test from Baseline to 12 Weeks (Arm B)	The FRT test is used to quantify balance ability. A participant is instructed to flex the test arm forward to 90 degrees and to reach forward as far as possible before taking a step. The reach is determined by the total excursion of the third metacarpal from the starting point (with the handheld in a fist) to the point just before balance is lost. The final score is the average of three measurements.	Baseline to 12 weeks
Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm A)	Assessed by the Berg Balance Scale (BBS), the incidence of falls, fall-related injuries, the Functional Reach Test (FRT) to measure dynamic balance and muscle flexibility (lower scores indicating higher fall risk), the Single Leg Stance Test (SLS) to evaluate static balance with eyes open and closed (abnormal values indicating balance impairment), the Timed Up and Go (TUG) test, the 30-second Chair Stand (30CS) test to assess motor performance (with lower TUG scores and higher 30CS scores reflecting better functional balance, strength, and endurance), and gait speed measurement across an 8-meter hallway under three conditions (quiet walking, fast speed, and cognitive dual task) at baseline and after 12 weeks of Tai Chi training.	Baseline and 12 weeks
Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm B)	Assessed by the Berg Balance Scale (BBS), the incidence of falls, fall-related injuries, the Functional Reach Test (FRT) to measure dynamic balance and muscle flexibility (lower scores indicating higher fall risk), the Single Leg Stance Test (SLS) to evaluate static balance with eyes open and closed (abnormal values indicating balance impairment), the Timed Up and Go (TUG) test, the 30-second Chair Stand (30CS) test to assess motor performance (with lower TUG scores and higher 30CS scores reflecting better functional balance, strength, and endurance), and gait speed measurement across an 8-meter hallway under three conditions (quiet walking, fast speed, and cognitive dual task) at baseline and after 12 weeks of Tai Chi training.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Ting Bao, MD, Dana-Farber Cancer Institute

Publications and helpful links

Helpful Links

• Recruitment Website

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Tai Chi; Balance training; Cancer survivor; Pilot study; Feasibility study; CIPN; Peripheral Neuropathy; Non-pharmacological intervention; Chemotherapy Induced Peripheral Neuropathy; Falls prevention; Mind-body exercise
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 24-399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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: [contact information for 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No