CancerNCT07019259
Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
A study testing Anodyne Therapy System in people with Cancer and Childhood Cancer, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Cancer, Childhood Cancer, Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- Anodyne Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Yale New Haven Health Smilow York Street Hospital
New Haven, Connecticut, 06520
- Recruiting
Yale New Haven Health Park Avenue Medical Center
Trumbull, Connecticut, 06611
About this study
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.
Read the 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.
- Being tested
- Anodyne Therapy System
- Keywords
- Survivors of childhood cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodyne Therapy SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Light Therapy | Experimental | Week 1 will include a baseline evaluation in clinic. In weeks 1-6, participants will complete 18 total light therapy sessions (3 sessions/week, 15/minutes session). The first session will be observed in clinic at the time of the baseline evaluation, and the remaining 17 sessions will be completed at home. In Week 7 survivors will follow-up in clinic for a repeat evaluation with the physical therapist (or study team member). . Receives: Device: Anodyne Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 weeks
Secondary outcomes (4)
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.
Measured: 7 weeks
Barriers and facilitators
List of perceived barriers and facilitators to the intervention derived from qualitative interviews.
Measured: 7 weeks
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.
Measured: baseline and 7 weeks
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.
Measured: baseline and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start30 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Rally Foundation for Childhood Cancer Research
- Responsible party
- Sponsor
- Investigators
- Rozalyn Rodwin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019259
- Sponsor's protocol ID
- 2000038498
- Status last verified
- Jun 2026
- First submitted
- 23 May 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT07019259
- Acronym / sponsor ID
- 2000038498
- Keywords
- Survivors of childhood cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Rally Foundation for Childhood Cancer Research
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light Therapy | Experimental | Device: Anodyne Therapy SystemWeek 1 will include a baseline evaluation in clinic. In weeks 1-6, participants will complete 18 total light therapy sessions (3 sessions/week, 15/minutes session). The first session will be observed in clinic at the time of the baseline evaluation, and the remaining 17 sessions will be completed at home. In Week 7 survivors will follow-up in clinic for a repeat evaluation with the physical therapist (or study team member). . |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodyne Therapy SystemSurvivors 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. | Device | Light Therapy |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rozalyn Rodwin, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodyne Therapy System in people with Cancer and Childhood Cancer, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rozalyn Rodwin, MD (203-785-2407, rozalyn.rodwin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of light therapy protocol (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.