Photobiomodulation for Cancer-Related Cognitive Impairment
NCT ID: NCT05855694
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-04-30
2029-04-30
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention Arm - Therapeutic Setting
Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks
THOR LED Photobiomodulation Helmet - Therapeutic
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
Control Arm - Non-Therapeutic Setting
Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks
THOR LED Photobiomodulation Helmet - Control
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
Interventions
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THOR LED Photobiomodulation Helmet - Therapeutic
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
THOR LED Photobiomodulation Helmet - Control
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
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Thor
UNKNOWN
Arash Asher, MD
OTHER
Responsible Party
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Arash Asher, MD
Director, Cancer Survivorship and Rehabilitation, Patient and Family Support Program
Principal Investigators
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Arash Asher, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Clinical Trial Recruitment Navigator
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT2022-14-ASHER-HELMET
Identifier Type: -
Identifier Source: org_study_id
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