Pilot Study of Photobiomodulation for Cancer-Related Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cognitive Symptoms
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Intervention Arm - Therapeutic Setting
Photobiomodulation Helmet, Therapeutic setting, 35mW/cm2 = 42J/cm2, 3 x Sessions per week for 6 weeks
干预措施: THOR LED Photobiomodulation Helmet - Therapeutic (Device)
Control Arm - Non-Therapeutic Setting
Photobiomodulation Helmet, Non-Therapeutic setting, 0mW/cm cm2 = 0J/cm2, 3 x Sessions per week for 6 weeks
干预措施: THOR LED Photobiomodulation Helmet - Control (Device)
结局指标
主要结局
Cognitive Symptoms
时间窗: 1-Month Follow Up
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.
次要结局
- Depression(1-Month Follow Up)
- Anxiety(1-Month Follow Up)
- Quality of Life(1-Month Follow Up)
- Cognitive Abilities(1-Month Follow Up)
研究者
Arash Asher, MD
Director, Cancer Survivorship and Rehabilitation, Patient and Family Support Program
Cedars-Sinai Medical Center