Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Anodyne Therapy System
DeviceSurvivors 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Light TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
Acceptability of light therapy for CIPN
Proportion of participants reporting satisfaction with the intervention, measured by a participant survey assessing satisfaction on a 4-point Likert scale (1-very dissatisfied, 2-somewhat dissatisfied, 3-somewhat satisfied, 4-very satisfied), total score range 1-4 with a mean score of 3 or higher indicating satisfaction.
Time frame
7 weeks2
Barriers and facilitators
List of perceived barriers and facilitators to the intervention derived from qualitative interviews.
Time frame
7 weeks3
Change in gait efficiency
Measured by change in 6-minute walk distance from baseline to completion of the intervention. It measures the distance an individual can walk over a total of six minutes on a hard, flat surface.
Time frame
baseline and 7 weeks4
Changes in neuropathy symptoms
Measured by the pediatric modified Total Neuropathy Score (ped-mTNS for survivors \<18 years old) and the modified Total Neuropathy Score (mTNS, for survivors 18 years or older) from baseline to completion of the intervention. For ped-mTNS the total score ranges from 0 to 32, with higher scores indicating more severe neuropathy. For ped-mTNS the total score ranges from 0 to 24, with higher scores indicating more severe neuropathy.
Time frame
baseline and 7 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Rally Foundation for Childhood Cancer Research
Collaborator
Source ClinicalTrials.gov