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Trial Title:
Photobiomodulation for Cancer-Related Cognitive Impairment
NCT ID:
NCT05855694
Condition:
Cancer-related Cognitive Impairment
Conditions: Official terms:
Cognitive Dysfunction
Conditions: Keywords:
Cancer Survivor
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
THOR LED Photobiomodulation Helmet - Therapeutic
Description:
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
Arm group label:
Intervention Arm - Therapeutic Setting
Intervention type:
Device
Intervention name:
THOR LED Photobiomodulation Helmet - Control
Description:
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
Arm group label:
Control Arm - Non-Therapeutic Setting
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
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinical Trial Recruitment Navigator
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Contact:
Last name:
Clinical Trial Recruitment Navigator
Phone:
310-423-2133
Email:
cancer.trial.info@cshs.org
Investigator:
Last name:
Jamie Myers, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Praveen Arany, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Joel Epstein, DMD
Email:
Sub-Investigator
Investigator:
Last name:
Arash Asher, MD
Email:
Principal Investigator
Start date:
September 2024
Completion date:
February 2027
Lead sponsor:
Agency:
Arash Asher, MD
Agency class:
Other
Collaborator:
Agency:
Thor
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05855694
