What this study is
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.
What's being tested
- Anodyne Therapy System
Intervention · 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.
Study details
- Sponsor
- Yale University
- Conditions
- Cancer · Childhood Cancer · Chemotherapy-induced Peripheral Neuropathy
- Enrolling
- 20 people
- Starts
- 2025-06-30
- Est. completion
- 2027-04
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openYale New Haven Health Smilow York Street Hospital
New Haven, Connecticut, United States
RecruitingYale New Haven Health Park Avenue Medical Center
Trumbull, Connecticut, United States
Recruiting
Study team
Sponsor
Yale University
Study ID 2000038498
Principal investigator
Rozalyn Rodwin, MD
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.