Photobiomodulation for Cancer-Related Cognitive Impairment

Arash Asher, MD

Status: Begins enrollment in 1 month

Conditions: Cancer-related Cognitive Impairment

Treatments: Device: THOR LED Photobiomodulation Helmet - Therapeutic; Device: THOR LED Photobiomodulation Helmet - Control

Study type: Interventional

Funder types: Other

Identifiers

NCT05855694

IIT2022-14-ASHER-HELMET

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Intervention Arm - Therapeutic Setting

Experimental group

Description:

Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks

Treatment:

Device: THOR LED Photobiomodulation Helmet - Therapeutic

Control Arm - Non-Therapeutic Setting

Sham Comparator group

Description:

Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks

Treatment:

Device: THOR LED Photobiomodulation Helmet - Control