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Photobiomodulation for Cancer-Related Cognitive Impairment

ConditionCancer-related Cognitive Impairment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArash Asher, MD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intervention Arm - Therapeutic SettingExperimental treatment 1 intervention
Group B: Control Arm - Non-Therapeutic SettingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1-Month Follow Up

Secondary outcomes

1

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.

Time frame
1-Month Follow Up
2

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.

Time frame
1-Month Follow Up
3

Depression

Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20, with higher score representing better outcomes.

Time frame
1-Month Follow Up
4

Anxiety

Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20. with higher score representing better outcomes.

Time frame
1-Month Follow Up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arash Asher, MD

Lead sponsor

Cedars-Sinai Medical Center

Sponsor institution

Thor

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: