Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation
研究概览
简要总结
This pilot trial studies how well systemic light exposure works in preventing frailty in older patients with prostate cancer on hormonal therapy. Hormone therapy causes many symptoms of frailty in older men including fatigue, slower time to walk a specified distance, reduced activity levels, loss of lean muscle, and muscle weakness. It is not yet known if systemic light exposure may reduce frailty in older prostate cancer patients.
详细描述
PRIMARY OBJECTIVES:
I. Determine if bright white light (BWL), compared to dim white light (DWL), significantly prevents frailty development in older prostate cancer (PC) patients following prostate anti-androgen therapy initiation.
II. Determine if BWL, compared to DWL, significantly increases functional performance and physical activity levels, yields significant reductions in fatigue, lowers body mass index (BMI), and reduces weakness in older PC patients following prostate anti-androgen therapy initiation.
EXPLORATORY OBJECTIVE:
I. Examine the feasibility of collecting and storing clinically-usable bio-measures for future analysis in patients at baseline and if available at 6 months, including blood samples (inflammatory markers), and salivary swabs (genetics, genomics, cortisol circadian rhythms).
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer (PC) patients who are starting androgen deprivation therapy (ADT), abiraterone, or enzalutamide with plans to continue for at least six months with minimal evidence of disease burden in accordance with current standards of care.
- •A life expectancy of 6 months or longer.
- •All subjects must have the ability to understand and the willingness to sign a written or electronic informed consent.
排除标准
- •Significant pre-existing frailty precluding completion of baseline assessments.
- •Other active malignancies
- •Previous use of radiation therapy within the year prior to consent.
- •Widely metastatic disease.
- •Confounding serious medical illnesses which causes frailty.
- •Severe sleep disorders.
- •Eye diseases which limit the ability of light to be processed.
- •Severe psychological impairment.
- •Current employment in night shift work.
- •Previous use of light therapy to alleviate fatigue or depressive symptoms.
- •Secondary cancer diagnosis within the past 5 years.
- •Plans to travel across meridians during treatment.
- •Uncontrolled illness including ongoing or active infection in disease status patients.
结局指标
主要结局
Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation
时间窗: Up to 6 months
Will be assessed using Short Physical Performance Battery (SPPB). Will be evaluated using a repeated measures mixed linear model.
Frailty development in older PC patients following prostate anti-androgen therapies initiation
时间窗: Up to 6 months
Will be assessed using SPPB. Will be evaluated using a repeated measures mixed linear model.
次要结局
- Hand-grip strength measured using hand-held dynamometer(Up to 6 months)
- Physical performance(Up to 6 months)
- Fatigue level(Up to 6 months)
- Instrumental activities of daily living (IADL) scale(Up to 6 months)
- Activity level(Up to 6 months)