Yoga for Peripheral Neuropathy

Recruiting at 13 trial locations

Overseen by Ting Bao, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must be taking: Anti-neuropathy medications

Disqualifiers: Recent physical therapy or yoga

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing if yoga can help reduce nerve pain caused by cancer treatment. It will compare yoga classes, educational sessions about nerve pain and yoga, and typical care. The study aims to see if yoga can improve balance, reduce falls, and enhance quality of life for patients with chemotherapy-induced nerve pain. Yoga has been shown to improve cancer-related fatigue and sleep quality in breast cancer patients during and following treatment.

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications, but you must be on a stable regimen (no changes in three months) if you're taking anti-neuropathy or other pain medications. You also cannot start any new pain medications during the first 12 weeks of the study.

What data supports the effectiveness of this treatment for peripheral neuropathy?

Research suggests that yoga and mindfulness practices can improve balance, body functions, and quality of life in people with diabetic peripheral neuropathy, which may be similar to chemotherapy-induced peripheral neuropathy. ^{1 2 3 4 5}

Is yoga safe for people with peripheral neuropathy?

Yoga is generally safe for people, including those with peripheral neuropathy. A review of 301 studies found no serious adverse events related to yoga, and a study on cancer survivors with chemotherapy-induced peripheral neuropathy reported no adverse events during an 8-week yoga program. ^{1 4 6 7 8}

How does the yoga treatment for peripheral neuropathy differ from other treatments?

Yoga for peripheral neuropathy is unique because it combines physical postures, breathing exercises, and meditation to improve balance, reduce stress, and enhance quality of life, unlike conventional treatments that may focus solely on medication or physical therapy. ^{1 4 8 9 10}

Research Team

Ting Bao, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for English-speaking adults over 18 who finished chemotherapy like platinum agents or taxanes at least three months ago and have nerve pain from it (CIPN). They should not have changed their pain meds in the last three months, can't start new ones during the study, and haven't done yoga or physical therapy for CIPN recently.

Inclusion Criteria

I finished chemotherapy that can affect nerves 3 months ago.

I haven't changed my pain or neuropathy medication in the last 3 months and don't take acetyl-L-carnitine.

I have moderate to severe nerve pain from chemotherapy, scoring 4 or more on a pain scale.

Exclusion Criteria

I have not done physical therapy or yoga for CIPN in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will receive one of three approaches: yoga classes, educational sessions, or usual care with standard-of-care medications for CIPN over the course of 8 weeks

8 weeks

16 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of balance, risk of falls, and quality of life

16 weeks

Treatment Details

Interventions

• Education control (Behavioural Intervention)
• Usual care (Behavioural Intervention)
• Yoga (Behavioural Intervention)

Trial Overview The study tests if yoga can help with nerve pain caused by chemo. Participants will either take yoga classes, attend educational sessions about CIPN and therapies, or receive usual care with standard medications. The effects on balance, fall risk, quality of life, and touch sensitivity are compared.

Participant Groups

Group I: Yoga Experimental Treatment 1 Intervention

Participants will receive twice weekly yoga over the course of 8 weeks.

Group II: Education control (EC) Experimental Treatment 1 Intervention

Participants will receive twice weekly education over the course of 8 weeks

Group III: Usual care (UC) Active Control 1 Intervention

8 weeks of usual care

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a pilot study involving 41 breast and gynecological cancer survivors, an 8-week yoga program showed a significant reduction in anxiety levels compared to a wait-list control group, particularly at week 12.

While yoga did not significantly impact depression, fatigue, or insomnia scores, the findings suggest that yoga may be a beneficial intervention for managing anxiety in patients with chemotherapy-induced peripheral neuropathy (CIPN).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes. Zhi, WI., Baser, RE., Zhi, LM., et al.[2022]

In a study of 120 patients with type 2 diabetic peripheral neuropathy, combining mindfulness training with aerobic exercise significantly improved neurological function, as shown by increased sensory and motor nerve conduction velocities (SNCV and MNCV) compared to other treatment methods.

The combination of mindfulness and aerobic exercise also led to better quality of life and reduced neurological symptoms, indicating that this approach is both safe and effective for enhancing the well-being of patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Mindfulness Training Combined with Aerobic Exercise on Neurological Function and Quality of Life in Patients with Peripheral Neuropathy Type 2 Diabetes Mellitus. Weng, X., Liao, S., Wang, F., et al.[2022]

In a pilot study involving 20 participants with diabetic neuropathy, mindfulness meditation did not show significant differences in overall outcomes between the treatment and control groups.

However, there were observed differences in pain quality of life and symptom-related quality of life, suggesting that mindfulness meditation may have potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness meditation on painful diabetic peripheral neuropathy in adults older than 50 years. Teixeira, E.[2022]

A 12-week study involving 35 participants with diabetic peripheral neuropathy showed that both Yogasana and conventional balance exercises improved balance performance and reduced fear of falling, with significant improvements in lower extremity strength.

The Yogasana intervention was found to be marginally more effective than conventional balance exercises in enhancing static and dynamic balance performance, indicating its potential as a beneficial exercise for individuals with diabetic neuropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Yogasana Intervention on Standing Balance Performance among People with Diabetic Peripheral Neuropathy: A Pilot Study. Kanjirathingal, JP., Mullerpatan, RP., Nehete, G., et al.[2022]

An 8-week Hatha Yoga program for ten individuals with diabetic peripheral neuropathy (DPN) led to improvements in neuromuscular and sensory functions, as well as better stress management and sleep quality.

The study highlights the holistic benefits of yoga for individuals with DPN, suggesting it can enhance overall well-being by positively impacting physical functions and social support, warranting further research with larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional Improvements in Health Following Hatha Yoga for Individuals with Diabetic Peripheral Neuropathy. Van Puymbroeck, M., Atler, K., Portz, JD., et al.[2020]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

An 8-week somatic yoga and meditation program for 8 individuals with chemotherapy-induced peripheral neuropathy (CIPN) showed significant improvement in CIPN symptoms, as measured by the FACT-GOG-Ntx scale, indicating potential efficacy of this intervention.

Participants reported improved self-confidence and balance, with no adverse events, suggesting that somatic yoga and meditation may be a safe and beneficial complementary therapy for managing CIPN in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy. Galantino, ML., Brooks, J., Tiger, R., et al.[2020]

Self-management strategies initiated by patients with peripheral neuropathy, such as heat therapy, exercise, meditation, and TENS therapy, may help reduce symptoms like pain and numbness, potentially improving their quality of life.

The review included 16 studies but highlighted that the overall quality of these studies was low, indicating a need for more rigorous research to confirm the effectiveness of these self-management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the effectiveness of self-initiated interventions to decrease pain and sensory disturbances associated with peripheral neuropathy. Ogle, T., Alexander, K., Miaskowski, C., et al.[2020]

A 10-month therapeutic yoga program significantly improved the quality of life, lower back pain, and balance in a 61-year-old man with adrenomyeloneuropathy, demonstrating the potential benefits of yoga for neurodegenerative diseases.

The study suggests that yoga therapy, which includes hatha yoga poses and breathing exercises, is a low-risk and low-cost intervention that could be beneficial for individuals with various neurological disorders, warranting further research into its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga as Therapy for Neurodegenerative Disorders: A Case Report of Therapeutic Yoga for Adrenomyeloneuropathy. Muhammad, CM., Moonaz, SH.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Yoga for cancer survivors with chemotherapy-induced peripheral neuropathy: Health-related quality of life outcomes. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of Mindfulness Training Combined with Aerobic Exercise on Neurological Function and Quality of Life in Patients with Peripheral Neuropathy Type 2 Diabetes Mellitus. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effect of mindfulness meditation on painful diabetic peripheral neuropathy in adults older than 50 years. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Effect of Yogasana Intervention on Standing Balance Performance among People with Diabetic Peripheral Neuropathy: A Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Multidimensional Improvements in Health Following Hatha Yoga for Individuals with Diabetic Peripheral Neuropathy. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Impact of Somatic Yoga and Meditation on Fall Risk, Function, and Quality of Life for Chemotherapy-Induced Peripheral Neuropathy Syndrome in Cancer Survivors. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Somatic Yoga and Meditation: A Pilot Study in a Multicultural Cancer Survivor Population with Chemotherapy-Induced Peripheral Neuropathy. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Systematic review of the effectiveness of self-initiated interventions to decrease pain and sensory disturbances associated with peripheral neuropathy. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Yoga as Therapy for Neurodegenerative Disorders: A Case Report of Therapeutic Yoga for Adrenomyeloneuropathy. [2020]