Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tai Chi Program.
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN), Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathies, Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Enrollment Rate for the Tai Chi Program [Time frame: 6 months]
- Assessment Completion Rate [Time frame: 12 weeks]
- Session Completion Rate [Time frame: 12 weeks]
- Acceptability of Intervention Measure (AIM) Score [Time frame: 12 weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06807294 · 24-399