NCT07019259 · Yale University
Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
Feasibility of light therapy protocol
Time frame: 7 weeks
Measured as proportion of participants adhering to protocol (completing 12 of 18 sessions), with ≥70% of participants adhering to the protocol indicating feasibility
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New Haven, Connecticut
- Trumbull, Connecticut
Collaborators
Rally Foundation for Childhood Cancer Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations