NCT03661437

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DEVICE	Actigraph	Wear Actiwatch
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Systematic Light Exposure	Undergo BWL treatment
PROCEDURE	Systematic Light Exposure	Receive DWL treatment

Timeline

• Start date: 2018-09-24
• Primary completion: 2020-07-10
• Completion: 2025-03-24
• First posted: 2018-09-07
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study