Photobiomodulation for Cancer-Related Cognitive Impairment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THOR LED Photobiomodulation Helmet - Therapeutic, THOR LED Photobiomodulation Helmet - Control.
- Who it may be relevant to
- Registry conditions: Cancer-related Cognitive Impairment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
Overview
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
Interventions
- Device 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 - Device 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
Primary outcome measures
- Cognitive Symptoms [Time frame: 1-Month Follow Up]
Secondary outcome measures (4)
- 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]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Clinical Trial Recruitment Navigator — Los Angeles
Identifiers
NCT: NCT05855694 · IIT2022-14-ASHER-HELMET