Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anodyne Therapy System.
- Who it may be relevant to
- Registry conditions: Cancer, Childhood Cancer, Chemotherapy-induced Peripheral Neuropathy. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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]
Secondary outcome measures (4)
- Acceptability of light therapy for CIPN [Time frame: 7 weeks]
- Barriers and facilitators [Time frame: 7 weeks]
- Change in gait efficiency [Time frame: baseline and 7 weeks]
- Changes in neuropathy symptoms [Time frame: baseline and 7 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 2 centers
- Yale New Haven Health Smilow York Street Hospital — New Haven
- Yale New Haven Health Park Avenue Medical Center — Trumbull
Identifiers
NCT: NCT07019259 · 2000038498