Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (BWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo BWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months. ARM II (DWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo DWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

Official Title
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Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Device: Actigraph
* Other: Questionnaire Administration
* Procedure: Systematic Light Exposure
* Procedure: Systematic Light Exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (BWL)<br>Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo BWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months. | Device: Actigraph<br>* Wear Actiwatch<br>* Other names: Actigram;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Systematic Light Exposure<br>* Undergo BWL treatment<br>* Other names: sLE;|
| Experimental: Arm II (DWL)<br>Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo DWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months. | Device: Actigraph<br>* Wear Actiwatch<br>* Other names: Actigram;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Systematic Light Exposure<br>* Receive DWL treatment<br>* Other names: sLE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation | Will be assessed using Short Physical Performance Battery (SPPB). Will be evaluated using a repeated measures mixed linear model. | Up to 6 months | 
| Frailty development in older PC patients following prostate anti-androgen therapies initiation | Will be assessed using SPPB. Will be evaluated using a repeated measures mixed linear model. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue level | Will be measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Will be evaluated using a repeated measures mixed linear model. | Up to 6 months | 
| Physical performance | Will be assessed by measuring the waist and hip circumference using a fabric measuring tape to determine the circumference of the waist (centered at the umbilicus) and hip (centered on the greater trochanter). Will be evaluated using a repeated measures mixed linear model. | Up to 6 months | 
| Hand-grip strength measured using hand-held dynamometer | Muscle weakness will be measured by grip strength. Will be evaluated using a repeated measures mixed linear model. | Up to 6 months | 
| Instrumental activities of daily living (IADL) scale | Will be evaluated using a repeated measures mixed linear model. | Up to 6 months | 
| Activity level | Activity counts will be recorded with the Actiwatch Spectrum Plus for five days at each time-point. Will be evaluated using a repeated measures mixed linear model. | Up to 6 months |