Clinical trial NCT07019259: Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
Official title: Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Childhood Cancer
Chemotherapy-induced Peripheral Neuropathy
Keywords: Survivors of childhood cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Rally Foundation for Childhood Cancer Research
First posted: 2025-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Primary outcomes:
measure: Feasibility of light therapy protocol
timeFrame: 7 weeks
Secondary outcomes:
measure: Acceptability of light therapy for CIPN
timeFrame: 7 weeks
measure: Barriers and facilitators
timeFrame: 7 weeks
measure: Change in gait efficiency
timeFrame: baseline and 7 weeks
measure: Changes in neuropathy symptoms
timeFrame: baseline and 7 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health Smilow York Street Hospital
state: Connecticut
city: Trumbull
country: United States
facility: Yale New Haven Health Park Avenue Medical Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Rozalyn Rodwin, MD
role: PRINCIPAL_INVESTIGATOR
References: