At-home light therapy for chemo-related nerve pain in childhood cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.