Photobiomodulation for Cancer-Related Cognitive Impairment

Part of paid clinical trials in Los Angeles, California.

Sponsor
Arash Asher, MD
Study ID
NCT05855694
Status
Not Yet Recruiting

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Conditions

  • Cancer-related Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Arm - Therapeutic Setting
    Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks
  • Sham Comparator: Control Arm - Non-Therapeutic Setting
    Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks

Primary Outcome Measure

Cognitive Symptoms [ Time Frame: 1-Month Follow Up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trial Recruitment NavigatorLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Jamie Myers, PhD (SUB_INVESTIGATOR)
Praveen Arany, PhD (SUB_INVESTIGATOR)
Joel Epstein, DMD (SUB_INVESTIGATOR)
Arash Asher, MD (PRINCIPAL_INVESTIGATOR)

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Clinical Trial Recruitment Navigator· Los Angeles, CA