Tai Chi for Peripheral Neuropathy

Not yet recruiting at 1 trial location

Overseen By Ting Bao, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Recent physical therapy, Tai Chi, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 29

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 12-week virtual Tai Chi program can improve balance and nerve function in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). Participants will either join the Tai Chi group or remain on a waitlist with standard care, later receiving free Tai Chi sessions. Ideal candidates are cancer survivors who have undergone chemotherapy, are experiencing CIPN symptoms such as balance issues or fear of falling, and have not recently practiced Tai Chi or undergone physical therapy for CIPN. As an unphased trial, this study offers patients a unique opportunity to potentially enhance their quality of life through innovative, non-invasive therapy.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable regimen of your current anti-neuropathy or other pain medications, meaning no changes in the past three months. Additionally, you cannot start any new pain medications during the study.

What prior data suggests that this Tai Chi program is safe for cancer survivors with chemotherapy-induced peripheral neuropathy?

Research has shown that Tai Chi is a safe and beneficial exercise for individuals with peripheral neuropathy, a condition causing numbness, tingling, and balance issues. Studies have found that Tai Chi can enhance balance and improve posture. For example, among 508 individuals with peripheral neuropathy, Tai Chi led to better performance in balance tests, such as standing on one leg or walking for six minutes.

In another study on chemotherapy-induced peripheral neuropathy (CIPN), Tai Chi improved balance and reduced the risk of falls for cancer survivors. These studies report no serious side effects from Tai Chi, making it a well-tolerated practice for those with CIPN. Overall, Tai Chi appears to be a safe method to enhance balance and nerve function in individuals with this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tai Chi for treating peripheral neuropathy because it offers a non-drug approach to managing symptoms, which is different from the typical pain medications or topical treatments currently used. Tai Chi is a gentle exercise combining movement, meditation, and breathing, which may improve balance, reduce pain, and enhance quality of life without the side effects associated with medications. Additionally, it empowers patients to take an active role in their own care through regular, independent practice, potentially offering long-term benefits.

What evidence suggests that Tai Chi might be an effective treatment for peripheral neuropathy?

Studies have shown that Tai Chi can significantly improve balance and movement in people with peripheral neuropathy, a condition characterized by nerve damage that causes weakness, numbness, and pain. For example, research involving 508 participants found that Tai Chi improved balance, as measured by tests like standing on one leg and walking for six minutes. Additionally, regular Tai Chi practice has been reported to enhance the ability to feel and move, which is crucial for maintaining balance. Another study found that a 12-week Tai Chi program improved nerve signal transmission. In this trial, participants in the Tai Chi Treatment Group will engage in a similar 12-week program. These findings suggest that Tai Chi may help improve symptoms in people with nerve damage caused by chemotherapy. ^{1 2 3 6 7}

Who Is on the Research Team?

Ting Bao, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for cancer survivors who are experiencing nerve damage (peripheral neuropathy) as a result of chemotherapy. Participants should be able to commit to a 12-week virtual Tai Chi program aimed at improving balance and nerve function.

Inclusion Criteria

I am a cancer survivor with no current signs of cancer.

I am older than 18 years.

I finished chemotherapy that can affect nerves 3 months ago.

Exclusion Criteria

I have had physical therapy or Tai Chi for nerve damage from chemotherapy in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including questionnaires and sensory and functional testing

1-2 weeks

2 visits (in-person)

Treatment

Participants in the Tai Chi group receive virtual Tai Chi sessions twice weekly and perform independent sessions three times a week

12 weeks

24 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

Waitlist Control Follow-up

Participants in the waitlist group receive standard CIPN care and are offered Tai Chi sessions after the follow-up period

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tai Chi Program

Trial Overview The study is testing the feasibility and acceptability of a virtual Tai Chi program over 12 weeks, designed specifically for individuals with chemotherapy-induced peripheral neuropathy, focusing on its potential benefits in balance and small nerve fiber function.

How Is the Trial Designed?

Group I: Arm A: Tai Chi Treatment Group Experimental Treatment 1 Intervention

14 randomized participants will complete: * 2 baseline visit sessions. * Virtual Tai Chi session 2x weekly. * Independent Tai Chi sessions 3 days a week. * 12 week follow up visit.

Group II: Arm B: Waitlist Control Group Active Control 1 Intervention

7 randomized participants will complete: * 2 baseline visit sessions * 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

A 12-week tai chi program led to long-term engagement in exercise for older adults with peripheral neuropathy, with participants continuing classes for an additional 18 months, highlighting the importance of psychosocial support in maintaining exercise routines.

Participants showed significant improvements in strength, balance, and stamina, confirming the physical benefits of tai chi, although changes in quality of life scores were not statistically significant, qualitative feedback indicated meaningful improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Tai Chi on Peripheral Neuropathy Revisited: A Mixed-Methods Study. Hermanns, M., Haas, BK., Rath, L., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0965229924000773

Tai Chi for balance and postural control in people with ... We found that among 508 participants with clinical peripheral neuropathy, Tai Chi significantly improved single leg stance, 6-min walk, timed up-and-go tests, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6299306/

Impact of Tai Chi on Peripheral Neuropathy Revisited The regular practice of TC has shown positive results in people with PN who experience sensory and motor deficits that adversely affect balance ...

3. dfhcc.harvard.edu dfhcc.harvard.edu/fileadmin/media/events/Celebration_of_Junior_Investigators/2024_posters/Yang__Mingxiao_Poster.pdf

Tai Chi for Chemotherapy-Induced Peripheral Neuropathy Current evidence indicates that Tai Chi may enhance balance in people with PN, leading us to design a randomized trial examining its feasibility in cancer ...

4. mdpi.com mdpi.com/2227-9032/11/11/1559

Effects of Tai Chi on Postural Control in People with ... Tai Chi training restores postural control by reducing the neuropathy total symptom score (TSS) [23], delaying proprioceptive declination by ...

5. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/17942

Effect of 12-week tai chi chuan exercise on peripheral ... A 12-week tai chi chuan programme significantly improved fasting blood glucose (p = 0.035) and increased nerve conduction velocities in all nerves tested.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01980368

Tai Chi Easy in Treating Cancer Survivors With Peripheral ... Study Overview. Brief Summary. This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors with peripheral sensory neuropathy.

7. esmoopen.com esmoopen.com/article/S2059-7029(25)01434-6/fulltext

Improving chemotherapy-induced peripheral neuropathy in ... A combined qigong and acupressure intervention versus waitlist control significantly improved self-reported CIPN among cancer patients.