Clinical trial NCT06807294: Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
Official title: Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Peripheral Neuropathy Due to Chemotherapy
Peripheral Neuropathies
Keywords: Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* 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?" "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; and
* ECOG Performance Status Scale score ≤ 2
* Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, two separate in- person visits to DFCI and Osher Center within 2 weeks of enrollment, and separate in-person visits to DFCI and Osher Center at week 12, and no new pain medication allowed throughout the study period.

Note: Participants receiving endocrine therapy or targeted/antibody therapy (examples including trastuzumab, perturzumab, immunotherapy) will be eligible.

Exclusion Criteria:

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

Primary outcomes:
measure: Enrollment Rate for the Tai Chi Program
timeFrame: 6 months
measure: Assessment Completion Rate
timeFrame: 12 weeks
measure: Session Completion Rate
timeFrame: 12 weeks
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Consent Rate (Arm A)
timeFrame: Up to 6 months (based on total accrual duration)
measure: Consent Rate (Arm B)
timeFrame: Up to 6 months (based on total accrual duration)
measure: Change in the Gait Health Assessment System from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline and 12 weeks
measure: Change in the Gait Health Assessment System from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline and 12 weeks
measure: Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline and 12 weeks
measure: Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline and 12 weeks
measure: Change in Fall Rate from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline and 12 weeks
measure: Change in Fall Rate from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline and 12 weeks
measure: Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline and 12 weeks
measure: Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline and 12 weeks
measure: Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline to 12 weeks
measure: Change in TUG Test from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline to 12 weeks
measure: Change in Brief Pain Inventory-Short For (BPI-SF) Score from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline to 12 weeks
measure: Change in BPI-SF Score from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline to 12 weeks
measure: Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline to 12 weeks
measure: Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline and 12 weeks
measure: Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline and 12 weeks
measure: Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline and 12 weeks
measure: Change in Vibration Threshold Value from Baseline to 12 weeks (Arm A)
timeFrame: Baseline to 12 weeks
measure: Change in Vibration Threshold Value from Baseline to 12 weeks (Arm B)
timeFrame: Baseline to 12 weeks
measure: Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline to 12 weeks
measure: Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline to 12 weeks
measure: Change in Functional Reach Test from Baseline to 12 Weeks (Arm A)
timeFrame: Baseline to 12 weeks
measure: Change in Functional Reach Test from Baseline to 12 Weeks (Arm B)
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mingxiao Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: