Photobiomodulation for Cancer-Related Cognitive Impairment

Not Applicable

Not yet recruiting

• Conditions: Cancer-related Cognitive Impairment
• Interventions: Device: THOR LED Photobiomodulation Helmet - Therapeutic; Device: THOR LED Photobiomodulation Helmet - Control

• Registration Number: NCT05855694
• Lead Sponsor: Arash Asher, MD

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm - Therapeutic Setting	THOR LED Photobiomodulation Helmet - Therapeutic	Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks
Control Arm - Non-Therapeutic Setting	THOR LED Photobiomodulation Helmet - Control	Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks

Primary Outcome Measures

Name	Time	Method
Cognitive Symptoms	1-Month Follow Up	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.

Secondary Outcome Measures

Name	Time	Method
Depression	1-Month Follow Up	Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20, with higher score representing better outcomes.
Anxiety	1-Month Follow Up	Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20. with higher score representing better outcomes.
Quality of Life	1-Month Follow Up	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.
Cognitive Abilities	1-Month Follow Up	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.

Trial Locations

Locations (1)

Clinical Trial Recruitment Navigator; 🇺🇸 Los Angeles, California, United States