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Photobiomodulation for Cancer-Related Cognitive Impairment

Primary Purpose

Cancer-related Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THOR LED Photobiomodulation Helmet - Therapeutic
THOR LED Photobiomodulation Helmet - Control
Sponsored by
Arash Asher, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer-related Cognitive Impairment focused on measuring Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Clinical Trial Recruitment Navigator

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention Arm - Therapeutic Setting

Control Arm - Non-Therapeutic Setting

Arm Description

Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks

Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2023
Last Updated
October 9, 2023
Sponsor
Arash Asher, MD
Collaborators
Thor
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1. Study Identification

Unique Protocol Identification Number
NCT05855694
Brief Title
Photobiomodulation for Cancer-Related Cognitive Impairment
Official Title
Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arash Asher, MD
Collaborators
Thor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Cognitive Impairment
Keywords
Cancer Survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm - Therapeutic Setting
Arm Type
Experimental
Arm Description
Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks
Arm Title
Control Arm - Non-Therapeutic Setting
Arm Type
Sham Comparator
Arm Description
Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks
Intervention Type
Device
Intervention Name(s)
THOR LED Photobiomodulation Helmet - Therapeutic
Intervention 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
Intervention Type
Device
Intervention Name(s)
THOR LED Photobiomodulation Helmet - Control
Intervention 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
Primary Outcome Measure Information:
Title
Cognitive Symptoms
Description
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 Outcome Measure Information:
Title
Cognitive Abilities
Description
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
Title
Quality of Life
Description
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
Title
Depression
Description
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
Title
Anxiety
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arash Asher, MD
Phone
424-315-0250
Email
arash.asher@cshs.org
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer Clinical Trials Office
Phone
3104232133
Email
Cancer.Trials.Info@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Recruitment Navigator
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Recruitment Navigator
Phone
310-423-2133
Email
cancer.trial.info@cshs.org
First Name & Middle Initial & Last Name & Degree
Jamie Myers, PhD
First Name & Middle Initial & Last Name & Degree
Praveen Arany, PhD
First Name & Middle Initial & Last Name & Degree
Joel Epstein, DMD
First Name & Middle Initial & Last Name & Degree
Arash Asher, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Photobiomodulation for Cancer-Related Cognitive Impairment

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