What side effects are associated with this type of intervention?

Common treatments for peripheral neuropathy include pharmacologic options like tricyclic antidepressants (e.g., amitriptyline), gabapentin, pregabalin, and duloxetine, which can cause side effects such as dizziness, drowsiness, dry mouth, and weight gain. Non-pharmacologic approaches like physical therapy, mindfulness meditation, and yoga generally have fewer side effects but may include muscle soreness or fatigue, especially in the initial stages. Overall, these treatments aim to improve physical function, reduce pain, and enhance well-being, with mindfulness and yoga offering additional benefits of stress reduction and emotional balance.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of peripheral neuropathy, particularly for neuropathic pain management. These include gabapentin and pregabalin, which are commonly used to alleviate pain and improve physical function. Tricyclic antidepressants like amitriptyline and serotonin-norepinephrine reuptake inhibitors (SNRIs) such as duloxetine have also been approved for their efficacy in reducing neuropathic pain. Additionally, alpha-lipoic acid has shown promise in improving symptoms and nerve conduction in diabetic polyneuropathy. While these medications focus on pain relief and functional improvement, integrative therapies like yoga are being studied for their potential to enhance overall well-being and quality of life in patients with chemotherapy-induced peripheral neuropathy.

What other types of research exist?

Promising novel alternatives to Yoga for Peripheral Neuropathy patients include: 1) Progressive Muscle Relaxation, which has been shown to reduce pain and improve quality of life; 2) Mindfulness Meditation, which has demonstrated benefits in pain management and overall well-being; 3) Treadmill Training with body weight support, which can improve motor symptoms and functional mobility; and 4) Music Therapy, which has been effective in reducing pain and improving psychological outcomes.

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Yoga for Peripheral Neuropathy

N/A

Recruiting

Led By Ting Bao, MD, DABMA, MS

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported moderate to severe CIPN pain, as defined by a score of 4 or greater on the BPI-SF average pain item over the past week

Willing to adhere to requirement that no new pain medication be taken throughout the first 12 weeks of the study period

Must not have

Patients who have received physical therapy or practiced yoga for CIPN in the past 3 months. As patients who have received physical therapy or practiced yoga in this time period may already be experiencing the benefits of yoga/stretching therapy, we will exclude such patients.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Yoga is generally safe but may include muscle soreness or strain. Usual care side effects depend on the specific medications used for CIPN treatment which can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I agree not to start any new pain medications for the first 12 weeks of the study.

Select...

I have been diagnosed with chemotherapy-induced peripheral neuropathy.

Select...

My cancer is stable or I am cancer-free according to my last check-up.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

measuring Chemotherapy-Induced Peripheral Neuropathy pain severity after Yoga

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: YogaExperimental Treatment1 Intervention

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

Group II: Education control (EC)Experimental Treatment1 Intervention

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

Group III: Usual care (UC)Active Control1 Intervention

8 weeks of usual care

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral neuropathy treatments aim to alleviate symptoms and improve quality of life. Common treatments include medications like gabapentin and tricyclic antidepressants, which work by modulating nerve signals to reduce pain. Exercise therapies, such as yoga, improve physical function, reduce pain, and enhance overall well-being by increasing blood flow, reducing inflammation, and promoting nerve health. These treatments are crucial as they address both the physical and psychological aspects of neuropathy, helping patients manage pain and improve their daily functioning.