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

NCT ID: NCT06807294Sponsor: Dana-Farber Cancer InstituteLast updated: 2026-01-29

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).

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.

Arms & interventions

  • BehavioralTai Chi Program

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

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 12 weeks

Secondary

  • Consent Rate (Arm A)

    Time frame: Up to 6 months (based on total accrual duration)

  • Consent Rate (Arm B)

    Time frame: 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)

    Time frame: Baseline and 12 weeks

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

    Time frame: Baseline and 12 weeks

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

    Time frame: Baseline and 12 weeks

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

    Time frame: Baseline and 12 weeks

  • Change in Fall Rate from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline and 12 weeks

  • Change in Fall Rate from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline and 12 weeks

  • Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline and 12 weeks

  • Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline and 12 weeks

  • Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline to 12 weeks

  • Change in TUG Test from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline to 12 weeks

  • Change in Brief Pain Inventory-Short For (BPI-SF) Score from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline to 12 weeks

  • Change in BPI-SF Score from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline to 12 weeks

  • Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline to 12 weeks

  • Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline and 12 weeks

  • Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline and 12 weeks

  • Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline and 12 weeks

  • Change in Vibration Threshold Value from Baseline to 12 weeks (Arm A)

    Time frame: Baseline to 12 weeks

  • Change in Vibration Threshold Value from Baseline to 12 weeks (Arm B)

    Time frame: Baseline to 12 weeks

  • Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline to 12 weeks

  • Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline to 12 weeks

  • Change in Functional Reach Test from Baseline to 12 Weeks (Arm A)

    Time frame: Baseline to 12 weeks

  • Change in Functional Reach Test from Baseline to 12 Weeks (Arm B)

    Time frame: Baseline to 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Ting Bao, MD · Contact
857-215-2844ting_bao@dfci.harvard.edu
Peter Wayne, PhD · Contact
617-732-6271pwayne@bwh.harvard.edu
Ting Bao, MD · Principal Investigator