Yoga for Peripheral Neuropathy

Recruiting at 13 trial locations

Overseen By Jun Mao, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: Anti-neuropathy medications

Disqualifiers: Recent physical therapy or yoga

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

268 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether yoga can ease nerve pain caused by cancer treatment, specifically chemotherapy-induced peripheral neuropathy (CIPN). Participants will divide into three groups: those taking yoga classes, those attending educational sessions about CIPN and treatments, and those continuing with their usual care. The study aims to assess how these approaches affect balance, fall risk, quality of life, and any improvement in sensation. Individuals who have completed certain chemotherapy treatments and experience moderate to severe nerve pain might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore non-drug interventions that could enhance quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that yoga is safe for individuals experiencing nerve pain from chemotherapy. In studies with cancer survivors, yoga improved symptoms without causing harm. Participants reported no major negative effects while practicing yoga. This suggests that yoga is well-tolerated and could gently help manage nerve pain from cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using yoga for peripheral neuropathy because it offers a holistic approach that differs from traditional medications like pain relievers and antidepressants. Unlike these standard treatments, which often focus on symptom management, yoga incorporates physical postures, breathing exercises, and meditation to potentially improve nerve function and reduce pain. This non-invasive practice also promotes overall well-being, making it an appealing option for those looking to avoid medication-related side effects. Additionally, yoga's emphasis on mindfulness may help enhance patients' quality of life by reducing stress and improving mental health, which are often affected by chronic conditions like peripheral neuropathy.

What evidence suggests that this trial's treatments could be effective for chemotherapy-induced peripheral neuropathy?

Studies have shown that yoga can help with chemotherapy-induced peripheral neuropathy (CIPN), a type of nerve pain caused by cancer treatment. Research indicates that yoga reduces pain and the risk of falls while improving physical function. Some cancer survivors reported a better quality of life and less severe CIPN symptoms after practicing yoga. Additionally, yoga improved balance and sensory functions in those affected by CIPN. In this trial, participants will join different treatment arms, including a yoga program, to evaluate its effectiveness in managing CIPN symptoms. Overall, these findings suggest that yoga could be a helpful way to manage CIPN symptoms. ^{1 4 6 7 8}

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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Education control
• Usual care
• Yoga

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.

How Is the Trial Designed?

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+

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A somatic yoga and meditation (SYM) intervention over 8 weeks significantly improved flexibility, balance, and reduced fall risk in 10 participants with chemotherapy-induced peripheral neuropathy (CIPN), with no adverse events reported.

Participants also reported improved quality of life and a reduction in pain perception, suggesting that SYM may be a beneficial nonpharmacological approach for managing CIPN symptoms.

NCBI (Pubmed)

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. Galantino, ML., Tiger, R., Brooks, J., et al.[2020]

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]

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]

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]

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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7666827/

Yoga for Chemotherapy-Induced Peripheral Neuropathy ... Among breast and gynecological cancer survivors with moderate-to-severe CIPN, yoga was safe and showed promising efficacy in improving CIPN symptoms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8366077/

Yoga for cancer survivors with chemotherapy‐induced ... Our results showed that yoga reduced CIPN pain and fall risk, and improved physical functioning. Here, we report on health‐related quality of ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03824860

Yoga for Painful Chemotherapy-Induced Peripheral ... This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT404082

A randomized phase III clinical trial of yoga ... Our pilot study (NCT03292328) demonstrated that yoga reduced CIPN-related symptoms, and improved quality of life and functional reach scores compared to ...

5. ijyt.kglmeridian.com ijyt.kglmeridian.com/view/journals/ijyt/30/1/article-p49.xml

Effectiveness of Somatic Yoga and Meditation: A Pilot Study in ... They attended 81% of the sessions, and no adverse events we re re p o rted. CIPN symptoms (FAC T- G O G - N t x ) improved significantly (from ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03292328

Yoga for Symptoms of Nerve Damage Caused by ... The purpose of this study is to find out the effects of yoga on reducing symptoms caused by such nerve damage. Official Title. Yoga for Chemotherapy-Induced ...

7. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/yctstudy

Yoga for Chemotherapy-induced Peripheral Neuropathy ... The purpose of this study is to test whether yoga can reduce nerve pain caused by cancer treatment (chemotherapy-induced peripheral neuropathy, or CIPN).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8442518/

Yoga for chronic chemotherapy-induced peripheral ... Based on preliminary evidence suggesting that yoga appears to be a safe and feasible intervention for cancer survivors with chronic CIPN pain, ...