Photobiomodulation for Cancer-Related Cognitive Impairment

NCT05855694 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: IIT2022-14-ASHER-HELMET
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer-related Cognitive Impairment

Keywords

Cancer Survivor

Outcome Measures

Primary Outcomes (1)

• Cognitive Symptoms

  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.

  1-Month Follow Up

Secondary Outcomes (4)

• Cognitive Abilities

  1-Month Follow Up

• Quality of Life

  1-Month Follow Up

• Depression

  1-Month Follow Up

• Anxiety

  1-Month Follow Up

Study Arms (2)

Intervention Arm - Therapeutic Setting

EXPERIMENTAL

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

Device: THOR LED Photobiomodulation Helmet - Therapeutic

Control Arm - Non-Therapeutic Setting

SHAM COMPARATOR

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

Device: THOR LED Photobiomodulation Helmet - Control

Interventions

THOR LED Photobiomodulation Helmet - Therapeutic DEVICE

Photobiomodulation (PBM) is a non-invasive treatment option that uses nonionizing light sources such as laser diodes and light-emitting diodes in the visible and near-infrared spectrum. Each participant will be required to sit with the helmet device over their head for the length of their study session. Participants and study staff will wear protective goggles throughout each session. These goggles help to block out any red LED light emitted from the helmet device. Participants may experience a pleasant warmth upon their head during both the therapeutic and control settings. Helmet will be in 'therapeutic setting' of 35mW/cm2 = 42J/cm2

Intervention Arm - Therapeutic Setting

THOR LED Photobiomodulation Helmet - Control DEVICE

Each participant will be required to sit with the helmet device over their head for the length of their study session. Participants and study staff will wear protective goggles throughout each session. These goggles help to block out any red LED light emitted from the helmet device. Participants may experience a pleasant warmth upon their head during both the therapeutic and control settings. Helmet will be in 'non-therapeutic setting' of 0mW/cm2 = 0J/cm2

Control Arm - Non-Therapeutic Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arash Asher, MD: lead
• Thor: collaborator

Study Sites (1)

Clinical Trial Recruitment Navigator

Los Angeles, California, 90048, United States

Location

Study Officials

• Arash Asher, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Asher, MD

CONTACT

424-315-0250; arash.asher@cshs.org

Cancer Clinical Trials Office

CONTACT

3104232133; GroupCancerTrialInformation@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Cancer Survivorship and Rehabilitation, Patient and Family Support Program

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 11, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)