Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05855694 | NOT YET RECRUITING | Cancer-related Cognitive Impairment

Photobiomodulation for Cancer-Related Cognitive Impairment
Sponsor:

Arash Asher, MD

Information provided by (Responsible Party):

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

Condition or disease

Cancer-related Cognitive Impairment

Intervention/treatment

THOR LED Photobiomodulation Helmet - Therapeutic

THOR LED Photobiomodulation Helmet - Control

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : TRIPLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Photobiomodulation for Cancer-Related Cognitive Impairment

Location Details

NCT05855694

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Clinical Trial Recruitment Navigator

Los Angeles, California, United States, 90048