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| Name | Class |
|---|---|
| Thor | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm - Therapeutic Setting | Experimental | Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks |
|
| Control Arm - Non-Therapeutic Setting | Sham Comparator | Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-Month Follow Up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-Month Follow Up |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arash Asher, MD | Contact | 424-315-0250 | arash.asher@cshs.org | |
| Cancer Clinical Trials Office | Contact | 3104232133 | GroupCancerTrialInformation@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Arash Asher, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Recruitment Navigator | Los Angeles | California | 90048 | United States |
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| 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 |
|
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.
| 1-Month Follow Up |
| Depression | Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20, with higher score representing better outcomes. | 1-Month Follow Up |
| Anxiety | Depression will be measured by changes in scores the PROMIS-29. Scores can range from 4-20. with higher score representing better outcomes. | 1-Month Follow Up |