Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors

NCT07019259 | Recruiting FDA Device

• 1 other identifier: 2000038498
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Childhood Cancer; Chemotherapy-induced Peripheral Neuropathy

Keywords

Survivors of childhood cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of light therapy protocol

  Measured as proportion of participants adhering to protocol (completing 12 of 18 sessions), with ≥70% of participants adhering to the protocol indicating feasibility

  7 weeks

Secondary Outcomes (4)

• Acceptability of light therapy for CIPN

  7 weeks

• Barriers and facilitators

  7 weeks

• Change in gait efficiency

  baseline and 7 weeks

• Changes in neuropathy symptoms

  baseline and 7 weeks

Study Arms (1)

Light Therapy

EXPERIMENTAL

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). .

Device: Anodyne Therapy System

Interventions

Anodyne Therapy System 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.

Light Therapy

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Rally Foundation for Childhood Cancer Research: collaborator

Study Sites (2)

Yale New Haven Health Smilow York Street Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

Yale New Haven Health Park Avenue Medical Center

Trumbull, Connecticut, 06611, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rozalyn Rodwin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rozalyn Rodwin, MD

CONTACT

203-785-2407; rozalyn.rodwin@yale.edu

Jaime Rotatori, BSN, MS

CONTACT

203-785-2407; jaime.rotatori@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 13, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)