Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
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.
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.
Arms & interventions
- DeviceAnodyne 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.
Outcome measures
Primary
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
Time frame: 7 weeks
Secondary
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
Study locations (2)
Yale New Haven Health Smilow York Street Hospital
New Haven, Connecticut, 06520
Yale New Haven Health Park Avenue Medical Center
Trumbull, Connecticut, 06611