Photobiomodulation for Cancer-Related Cognitive Impairment

ConditionCancer-related Cognitive Impairment

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorArash Asher, MD

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

THOR LED Photobiomodulation Helmet - Therapeutic
THOR LED Photobiomodulation Helmet - Control

Treatment groups

30 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Arash Asher, MD

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Thor

Collaborator

Source ClinicalTrials.gov