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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
33
Wear Actiwatch
Ancillary studies
Undergo BWL treatment
City of Hope Medical Center
Duarte, California, United States
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.
Time frame: 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.
Time frame: Up to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 months
Instrumental activities of daily living (IADL) scale
Will be evaluated using a repeated measures mixed linear model.
Time frame: Up to 6 months
Activity level
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Receive DWL treatment
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.
Time frame: Up to 6 months