Recruiting

Light Therapy

Sponsor:

Yale University

Code:

NCT07019259

Conditions

Cancer

Childhood Cancer

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

Anodyne Therapy System

Study Details

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

Study ID

NCT07019259

Start date

Jun 30, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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). .

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.

Primary outcome measure

  • Feasibility of light therapy protocol [ Time Frame: 7 weeks ]

Central Contacts and Locations

Central contacts

Rozalyn Rodwin, MD

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

Jaime Rotatori, BSN, MS

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

Locations

Yale New Haven Health Smilow York Street Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Yale New Haven Health Park Avenue Medical Center

Recruiting

Trumbull, Connecticut, United States, 06611

More Information

Sponsor

Yale University

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Survivors of childhood cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-12.