Clinical trial NCT05855694: Photobiomodulation for Cancer-Related Cognitive Impairment
Official title: Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer-related Cognitive Impairment
Keywords: Cancer Survivor
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Thor
First posted: 2023-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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).

Primary outcomes:
measure: Cognitive Symptoms
timeFrame: 1-Month Follow Up
Secondary outcomes:
measure: Cognitive Abilities
timeFrame: 1-Month Follow Up
measure: Quality of Life
timeFrame: 1-Month Follow Up
measure: Depression
timeFrame: 1-Month Follow Up
measure: Anxiety
timeFrame: 1-Month Follow Up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clinical Trial Recruitment Navigator
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Arash Asher, MD
role: PRINCIPAL_INVESTIGATOR
References: