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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Peripheral Neuropathy Due to Chemotherapy; Chemotherapy Induced Peripheral Neuropathy (CIPN); Neuropathy; Peripheral Neuropathies

Treatments: Behavioral: Tai Chi Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06807294

24-399

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Arm A: Tai Chi Treatment Group

Experimental group

Description:

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.

Treatment:

Behavioral: Tai Chi Program

Arm B: Waitlist Control Group

No Intervention group

Description:

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.