Cancer-related Cognitive ImpairmentNCT05855694
Photobiomodulation for Cancer-Related Cognitive Impairment
A study testing THOR LED Photobiomodulation Helmet - Therapeutic in people with Cancer-related Cognitive Impairment, run by Arash Asher, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Cognitive Impairment
- What is being tested?
- THOR LED Photobiomodulation Helmet - Therapeutic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arash Asher, MD contact
United States1 site
Clinical Trial Recruitment Navigator
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Jamie Myers, PhD
About this study
Official title: Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
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
Read more
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
- Being tested
- THOR LED Photobiomodulation Helmet - Therapeutic, THOR LED Photobiomodulation Helmet - Control
- Keywords
- Cancer Survivor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THOR LED Photobiomodulation Helmet - TherapeuticDevice
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 - ControlDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Therapeutic Setting | Experimental | Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks Receives: 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 Receives: Device: THOR LED Photobiomodulation Helmet - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-Month Follow Up
Secondary outcomes (4)
Cognitive Abilities
Cognitive Abilities will be measured by changes in scores in the PROMIS Cognitive Function Abilities - Short Form 8a. Scores can range from 8-40. with higher score representing better outcomes.
Measured: 1-Month Follow Up
Quality of Life
Quality of Life will be measured by changes in scores the PROMIS-29. Scores can range from 30-140, with higher score representing better outcomes.
Measured: 1-Month Follow Up
Depression
Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20, with higher score representing better outcomes.
Measured: 1-Month Follow Up
Anxiety
Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20. with higher score representing better outcomes.
Measured: 1-Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arash Asher, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Thor
- Responsible party
- Sponsor-investigator, Arash Asher, MD, Cedars-Sinai Medical Center
- Investigators
- Arash Asher, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855694
- Sponsor's protocol ID
- IIT2022-14-ASHER-HELMET
- Status last verified
- Nov 2026
- First submitted
- 4 May 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05855694
- Acronym / sponsor ID
- IIT2022-14-ASHER-HELMET
- Conditions
- Cancer-related Cognitive Impairment
- Keywords
- Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arash Asher, MDUniversity, hospital or other
- Collaborators
- Thor
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Therapeutic Setting | Experimental | Device: THOR LED Photobiomodulation Helmet - TherapeuticPhotobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks |
| Control Arm - Non-Therapeutic Setting | Sham comparator | Device: THOR LED Photobiomodulation Helmet - ControlPhotobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THOR LED Photobiomodulation Helmet - TherapeuticPhotobiomodulation (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 | Device | Intervention Arm - Therapeutic Setting |
| THOR LED Photobiomodulation Helmet - ControlEach 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 | Device | Control Arm - Non-Therapeutic Setting |
Primary outcome
Cognitive Symptoms
Time frame: 1-Month Follow Up
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.
4 secondary outcomes
Cognitive Abilities
Time frame: 1-Month Follow Up
Quality of Life
Time frame: 1-Month Follow Up
Depression
Time frame: 1-Month Follow Up
Anxiety
Time frame: 1-Month Follow Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arash Asher, MD contact
Arash Asher, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THOR LED Photobiomodulation Helmet - Therapeutic in people with Cancer-related Cognitive Impairment, run by Arash Asher, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Symptoms (time frame: 1-Month Follow Up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.