Light Therapy for Peripheral Neuropathy

Recruiting at 1 trial location

Overseen By Jaime Rotatori, BSN, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnancy, Inability to sit, Active cancer, others

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

Compensation: Varies

Number of Visits: 20

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a light therapy treatment (Anodyne Therapy System) to assist childhood cancer survivors with Chemotherapy Induced Peripheral Neuropathy (CIPN), a condition causing numbness or pain in the hands and feet. The trial aims to determine if participants can easily use the light therapy at home for six weeks and if it reduces symptoms. Participants will undergo a baseline evaluation, complete 18 short therapy sessions over six weeks primarily at home, and then have a final check-up. This trial suits childhood cancer survivors with CIPN symptoms who received specific chemotherapy drugs. As an unphased trial, it offers a unique opportunity for participants to contribute to research that could enhance home-based treatments for CIPN.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this light therapy protocol is safe for childhood cancer survivors?

Research has shown that the Anodyne Therapy System, used in the light therapy trial, is generally safe. This system, a type of light therapy, has FDA approval for home or office use. Studies have found it can effectively increase blood flow in specific areas and aid in nerve pain and wound healing. Most people tolerate it well.

However, some considerations are necessary. The therapy is not recommended for pregnant women, individuals sensitive to light, or those with certain heart conditions. Major side effects have not been commonly reported, making it a promising option for many. Consulting a doctor is essential to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about light therapy for peripheral neuropathy because it offers a non-invasive approach that directly targets pain and nerve damage without the need for medications. Unlike traditional treatments like pain relievers or topical creams, light therapy uses specific wavelengths to potentially improve blood circulation and promote healing at the cellular level. This method could provide relief with minimal side effects and allow patients to perform most sessions conveniently at home, enhancing accessibility and ease of use.

What evidence suggests that the Anodyne Therapy System is effective for Chemotherapy Induced Peripheral Neuropathy?

Research on the Anodyne Therapy System, which participants in this trial will receive, has shown mixed results. Some studies suggest it may improve sensation and reduce pain in the lower body. However, other research found it no more effective than a placebo for enhancing nerve function in people with diabetes. Ongoing research into near-infrared light therapy has shown potential in reducing pain and burning sensations after a few sessions. Overall, while some findings are promising, the effectiveness of Anodyne therapy for conditions like peripheral neuropathy remains uncertain. ^{6 7 8 9 10}

Who Is on the Research Team?

Rozalyn Rodwin, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors who were diagnosed before turning 21, are now at least five years old, and have nerve damage from certain chemotherapy drugs. They must have a specific level of neuropathy as measured by a physical therapist.

Inclusion Criteria

I was diagnosed with cancer before turning 21.

I am at least five years old.

I have nerve damage from chemotherapy, as confirmed by a physical therapist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Evaluation

Baseline evaluation in clinic to assess initial neuropathy symptoms and conduct the first light therapy session

1 week

1 visit (in-person)

Treatment

Participants complete 18 light therapy sessions over 6 weeks, with 3 sessions per week at home

6 weeks

17 sessions (at-home), 1 session (in-person)

Follow-up

Participants are monitored for changes in neuropathy symptoms and gait efficiency post-treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anodyne Therapy System

Trial Overview The study tests a six-week home light therapy using the Anodyne Therapy System to see if it's doable and liked by participants. It also looks at how well it helps with symptoms of nerve damage caused by chemotherapy in these survivors.

How Is the Trial Designed?

Group I: Light Therapy Experimental Treatment 1 Intervention

Week 1 will include a baseline evaluation in clinic. In weeks 1-6, participants will complete 18 total light therapy sessions (3 sessions/week, 15/minutes session). The first session will be observed in clinic at the time of the baseline evaluation, and the remaining 17 sessions will be completed at home. In Week 7 survivors will follow-up in clinic for a repeat evaluation with the physical therapist (or study team member). .

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Rally Foundation for Childhood Cancer Research

Collaborator

Trials

6

Recruited

500+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK76072/

Effectiveness of the anodyne therapy system in treating ... - NCBI Anodyne therapy system treatment may be effective for improving lower extremity sensation, reducing pain, improving standard balance and decreasing fall risk.

2. diabetesjournals.org diabetesjournals.org/care/article/31/2/316/25228/Does-Anodyne-Light-Therapy-Improve-Peripheral

Does Anodyne Light Therapy Improve Peripheral Neuropathy ... The results of this study demonstrate that anodyne MIRE therapy provided no more improvement in peripheral sensation, balance, pain, or quality ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17977931/

Does anodyne light therapy improve peripheral neuropathy ... Conclusions: Anodyne MIRE therapy was no more effective than sham therapy in the treatment of sensory neuropathy in individuals with diabetes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00125268

Near Infrared Light for the Treatment of Painful Peripheral ... The purpose of this study is to determine if near infrared light therapy is effective in decreasing pain in patients with painful peripheral neuropathy.

5. nature.com nature.com/articles/s41598-024-78144-5

Development of a near infrared region based non-invasive ... Clear progression was followed in symptom relief: an average of 3 sessions reduced pain, 4 sessions reduced burning sensation, 5 sessions for ...

6. anodynetherapy.com anodynetherapy.com/health/anodyne-red-light-therapy-system/

anodyne red light therapy system It's a special light therapy delivered by an FDA-cleared medical device designed for home or office use. Anodyne® Therapy increases local circulation, providing ...

7. cms.gov cms.gov/medicare-coverage-database/view/ncacal-public-comments.aspx?ncaid=176

Infrared Therapy Devices (CAG-00291N) The Anodyne system has been very effective for the treatment of neuropathic pain and wound healing. We have had excellent success at my clinic helping patients.

8. aetna.com aetna.com/cpb/medical/data/600_699/0604.html

Infrared Therapy - Medical Clinical Policy Bulletins Does anodyne light therapy improve peripheral neuropathy in diabetes? A double-blind, sham-controlled, randomized trial to evaluate monochromatic infrared ...

9. anodynetherapy.com anodynetherapy.com/health/anodyne-therapy-side-effects/

Anodyne® Therapy Side Effects & Benefits | #1 Quality Care Anodyne Therapy is generally safe, but it's not recommended for pregnant women, individuals with light sensitivities, or those with certain heart conditions.

10. activehealth.com activehealth.com/content/2022/07/Anodyne-Therapy-AHM-1.pdf

Anodyne Therapy AHM The Anodyne Therapy System is a type of low-level infrared therapy, developed by Integrated Systems Physiology Inc. of Aurora, CO, that has been promoted for ...