At-home light therapy for chemo-related nerve pain in childhood cancer survivors
Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
This study tests whether a six-week at-home light therapy program can help childhood cancer survivors who have chemotherapy-induced peripheral neuropathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT07019259 on ClinicalTrials.gov |
What this trial studies
This prospective single-arm pilot enrolls survivors diagnosed before age 21 who are at least five years old and have chemotherapy-induced peripheral neuropathy defined by a modified Total Neuropathy Score ≥4. Participants will use an Anodyne light therapy device at home over six weeks and aim to complete at least 12 treatment sessions. The primary outcome is feasibility, defined as the proportion completing 12 or more sessions, with secondary outcomes including participant satisfaction, qualitative interviews on implementation barriers and facilitators, and change in neuropathy scores and gait speed measured one week after the intervention. Recruitment and follow-up occur through Yale New Haven Health clinics with remote at-home treatment.
Who should consider this trial
Good fit: Ideal participants are childhood cancer survivors diagnosed before age 21, currently aged five years or older, with prior exposure to vinca alkaloids, platinum, or similar neurotoxic chemotherapy and a documented mTNS/ped-mTNS score of four or higher.
Not a fit: Patients who are pregnant or lactating, have pre-existing neuropathy prior to cancer treatment, active cancer or lesions in the treatment area, central nervous system tumors, inability to sit still for 15 minutes, or open wounds where the device would be applied are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could offer a noninvasive, home-based option to reduce nerve pain and improve walking ability for childhood cancer survivors with CIPN.
How similar studies have performed: Photobiomodulation and low-level light therapies have shown mixed but sometimes promising results for adult peripheral neuropathy in small studies, while use specifically in childhood cancer survivors is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of childhood cancer (\<21 years of age at diagnosis) * Current age five years or older (due to availability of validated measures for CIPN in this age group) * History of exposure to vinca alkaloid, platinum, or other chemotherapeutic agent that can cause CIPN * CIPN as assessed by a trained physical therapist defined as a score of four or higher on the ped-mTNS (for survivors \<18 years old at evaluation), or the mTNS (for survivors 18 years or older at evaluation) Exclusion Criteria: * Currently Pregnant or lactating (by patient report, at initiation or at any point of the study) * Inability to sit still for at least 15 minutes * Diagnosis of neuropathy prior to cancer treatment * Active cancer diagnosis or cancerous skin lesion * Central nervous system tumor (due to lack of validated measures for CIPN in this population) * Cancer lesion or open wound in the area to be treated, or any condition that can potentially be made worse by the correct or incorrect use of the device.
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale New Haven Health Smilow York Street Hospital — New Haven, Connecticut, United States (Recruiting)
- Yale New Haven Health Park Avenue Medical Center — Trumbull, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Rozalyn Rodwin, MD — Yale University
- Study coordinator: Rozalyn Rodwin, MD
- Email: rozalyn.rodwin@yale.edu
- Phone: 203-785-2407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.