Studio pilota sulla fotobiomodulazione per il deterioramento cognitivo correlato al cancro
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
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Clinical Trial Navigator
- Numero di telefono: 310-423-5842
- Email: GroupCancerTrialInformation@cshs.org
Backup dei contatti dello studio
- Nome: Arash Asher, MD
- Email: arash.asher@csmc.edu
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90048
- Clinical Trial Recruitment Navigator
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Investigatore principale:
- Arash Asher, MD
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Sub-investigatore:
- Jamie Myers, PhD
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Sub-investigatore:
- Praveen Arany, PhD
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Sub-investigatore:
- Joel Epstein, DMD
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Contatto:
- Clinical Trial Recruitment Navigator
- Numero di telefono: 310-423-5842
- Email: GroupCancerTrialInformation@cshs.org
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervention Arm - Therapeutic Setting
Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks |
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 |
|
Comparatore fittizio: Control Arm - Non-Therapeutic Setting
Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks |
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cognitive Symptoms
Lasso di tempo: 1-Month Follow Up
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Cognitive Abilities
Lasso di tempo: 1-Month Follow Up
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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
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Quality of Life
Lasso di tempo: 1-Month Follow Up
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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
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Depression
Lasso di tempo: 1-Month Follow Up
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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
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Anxiety
Lasso di tempo: 1-Month Follow Up
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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
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Arash Asher, MD, Cedars-Sinai Medical Center
Studiare le date dei record
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IIT2022-14-ASHER-HELMET
Piano per i dati dei singoli partecipanti (IPD)
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