Photobiomodulation for Cancer-Related Cognitive Impairment

Study Overview
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Brief Summary
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This is a single site, pilot randomized, double blinded control trial designed to assess changes in cognitive symptoms in cancer survivors with cancer-related cognitive impairment. Patients will be randomized into one of two Arms: Intervention or Control. Arm A: Intervention Group: Use of the THOR LED Photobiomodulation helmet 3x per week for 6 weeks. Helmet will be in 'therapeutic setting', 35mW/cm2 = 42J/cm2 Arm B: Control Group: Use of the THOR LED Photobiomodulation helmet 3x per week for 6 weeks. Helmet will be in 'placebo setting', 0mW/cm2 = 0J/cm2 This study has been designed to assess the hypothesis that Photobiomodulation can have a positive impact on cognitive symptoms in cancer survivors with cancer-related cognitive impairment. 30 participants will be recruited for this study, 15 per group. Self-report questionnaires assessing cognitive concerns, cognitive abilities, quality of life, depression, and anxiety will be administered at three timepoints through the study Baseline, End of Study Visit and 1 Month Follow Up

Official Title
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Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment

Conditions
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Cancer-related Cognitive Impairment

Intervention / Treatment
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* Device: THOR LED Photobiomodulation Helmet - Therapeutic
* Device: THOR LED Photobiomodulation Helmet - Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years Previous diagnosis of stage I-III non-central nervous system solid tumor malignancy, Hodgkin, or Non-Hodgkin lymphoma Completed cancer treatment (chemotherapy and/or radiation) more than 6 months ago but less than 5 years ago (Current concurrent endocrine therapy, anti-HER-2 therapy allowed, or other stable maintenance therapies (such as rituximab) will be allowed. Self-reported cognitive complaints (score ≤ 54 on the Functional Assessment of Cancer Therapy-Cognition, Version 3, Perceived Cognitive Impairment subscale) Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Ability to read, write and understand either English OR Spanish. Exclusion Criteria: Current pregnancy or nursing status Current use of Photobiomodulation (PBM) (for any reason) A lifetime history of any brain tumor or central nervous system metastasis Previous use of intrathecal chemotherapy, chimeric antigen receptor treatment (CAR-T), or stem cell/marrow transplant Known history of other neurological conditions involving impaired cognitive function (such as Alzheimer's Disease and related dementias, Parkinson's Disease, or Multiple Sclerosis).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm - Therapeutic Setting<br>Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks | Device: THOR LED Photobiomodulation Helmet - Therapeutic<br>* Photobiomodulation (PBM) is a non-invasive treatment option that uses nonionizing light sources such as laser diodes and light-emitting diodes in the visible and near-infrared spectrum. Each participant will be required to sit with the helmet device over their head for the length of their study session. Participants and study staff will wear protective goggles throughout each session. These goggles help to block out any red LED light emitted from the helmet device. Participants may experience a pleasant warmth upon their head during both the therapeutic and control settings. Helmet will be in 'therapeutic setting' of 35mW/cm2 = 42J/cm2<br>|
| Sham Comparator: Control Arm - Non-Therapeutic Setting<br>Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks | Device: THOR LED Photobiomodulation Helmet - Control<br>* Each participant will be required to sit with the helmet device over their head for the length of their study session. Participants and study staff will wear protective goggles throughout each session. These goggles help to block out any red LED light emitted from the helmet device. Participants may experience a pleasant warmth upon their head during both the therapeutic and control settings. Helmet will be in 'non-therapeutic setting' of 0mW/cm2 = 0J/cm2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Symptoms | Cognitive symptoms will be measured by changes in scores on the PROMIS Cognitive Function-Short-Form 8a. Scores can range from 8-40. with higher score representing better outcomes. | 1-Month Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Abilities | Cognitive Abilities will be measured by changes in scores in the PROMIS Cognitive Function Abilities - Short Form 8a. Scores can range from 8-40. with higher score representing better outcomes. | 1-Month Follow Up | 
| Quality of Life | Quality of Life will be measured by changes in scores the PROMIS-29. Scores can range from 30-140, with higher score representing better outcomes. | 1-Month Follow Up | 
| Depression | Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20, with higher score representing better outcomes. | 1-Month Follow Up | 
| Anxiety | Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20. with higher score representing better outcomes. | 1-Month Follow Up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Survivor