NCT06807294

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Jan 2026Oct 2026

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
12 months until next milestone

Study Start

First participant enrolled

January 16, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 29, 2025

Last Update Submit

January 27, 2026

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)Peripheral Neuropathy Due to ChemotherapyPeripheral NeuropathiesNeuropathy

Keywords

Peripheral NeuropathyChemotherapy Induced Peripheral NeuropathyCancer survivorCIPNTai ChiBalance trainingFalls preventionNon-pharmacological interventionMind-body exerciseQuality of lifeFeasibility studyPilot study

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (24)

  • Consent Rate (Arm A)

    Up to 6 months (based on total accrual duration)

  • Consent Rate (Arm B)

    Up to 6 months (based on total accrual duration)

  • Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm A)

    Baseline and 12 weeks

  • Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm B)

    Baseline and 12 weeks

  • Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A)

    Baseline and 12 weeks

  • +19 more secondary outcomes

Study Arms (2)

Arm A: Tai Chi Treatment Group

EXPERIMENTAL

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

Arm B: Waitlist Control Group

NO INTERVENTION

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.

Interventions

Tai Chi ProgramBEHAVIORAL

12-week virtual Tai Chi program with experienced Tai Chi instructor. Sessions will be conducted via the HIPPA-compliant teleconference platform, Zoom.

Arm A: Tai Chi Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

  • Ting Bao, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Bao, MD

CONTACT

857-215-2844ting_bao@dfci.harvard.edu

Natalie Viyaran

CONTACT

natalie_viyaran@dfci.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

January 16, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data can be shared no earlier than 1 year following the date of publication
Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US(1)