Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors

NCT ID: NCT07019259

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-09-30

Brief Summary

The purpose of this study is to determine feasibility and acceptability of a six-week at-home light therapy protocol in childhood cancer survivors, to identify facilitators and barriers to implementing this intervention, and to measure signs and symptoms of Chemotherapy Induced Peripheral Neuropathy (CIPN) at baseline and following completion of the at-home light therapy protocol.

Detailed Description

This prospective single-arm pilot study will assess the feasibility of a 6-week at-home light therapy intervention for CIPN. Survivors of childhood cancer (<21 years at diagnosis), ages five years or older at the time of survivorship clinic visit, with a history of exposure to vinca alkaloid, platinum, or other chemotherapeutic agent that can cause CIPN, will be included if they have CIPN (defined as a score of four or higher on the pediatric modified Total Neuropathy Score for survivors <18 years old at evaluation, or the modified Total Neuropathy Score for survivors 18 years or older at evaluation). The primary outcome of the study will be feasibility of the at-home protocol, measured as proportion of survivors who complete at least 12 at-home light therapy sessions, with ≥70% of survivors completing 12 or more sessions indicating feasibility. Secondary outcomes include 1) Proportion of survivors satisfied with intervention, measured as a mean score of 3 or higher on a 4-point Likert-scale survey 2) Facilitators and barriers to implementation of light-therapy, assessed by semi-structured qualitative interviews with 5-10 survivors who adhered and did not adhere to the protocol, and 3) change in neuropathy symptoms (measured by change in modified Total Neuropathy Score or pediatric-modified Total Neuropathy Score, and gait speed) from baseline to 1 week post intervention.

Conditions

Cancer; Childhood Cancer; Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Light Therapy

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). .

Group Type: EXPERIMENTAL

Anodyne Therapy System

Intervention Type: DEVICE

Survivors will be provided the Anodyne Therapy System Model 120 to use as part of a 6-week at-home light therapy intervention. Participants will be instructed on where apply the device based on location of their symptoms, and will be instructed to use the device for 15 minutes per day, 3 days per week. Proper use of the device will be demonstrated in clinic by a trained physical therapist or study team member.

Interventions

Anodyne Therapy System

Survivors will be provided the Anodyne Therapy System Model 120 to use as part of a 6-week at-home light therapy intervention. Participants will be instructed on where apply the device based on location of their symptoms, and will be instructed to use the device for 15 minutes per day, 3 days per week. Proper use of the device will be demonstrated in clinic by a trained physical therapist or study team member.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rally Foundation for Childhood Cancer Research

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rozalyn Rodwin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Health Smilow York Street Hospital

New Haven, Connecticut, United States

Site Status: RECRUITING

Yale New Haven Health Park Avenue Medical Center

Trumbull, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rozalyn Rodwin, MD

Role: CONTACT

rozalyn.rodwin@yale.edu

203-785-2407

Jaime Rotatori, BSN, MS

Role: CONTACT

jaime.rotatori@yale.edu

203-785-2407

Other Identifiers

2000038498

Identifier Type: -

Identifier Source: org_study_id