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Light Exposure to Prevent Frailty in Prostate Cancer Patients

Phase < 1

Waitlist Available

Led By William Dale

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if light exposure can help prevent frailty in older prostate cancer patients on hormone therapy.

Who is the study for?

This trial is for older prostate cancer patients starting hormone therapy with minimal disease burden, who can sign consent and have a life expectancy of 6 months or more. It's not for those with severe sleep disorders, eye diseases affecting light processing, psychological impairments, night shift workers, recent secondary cancers, plans to travel across time zones during treatment, uncontrolled illnesses or infections.

What is being tested?

The study tests if systematic light exposure prevents frailty symptoms caused by hormone therapy in older men with prostate cancer. Frailty includes fatigue, slow walking speed, reduced activity levels, muscle loss and weakness. The trial involves questionnaires and actigraphy (movement monitoring) to assess the effects.

What are the potential side effects?

Since this trial focuses on light exposure rather than medication or invasive procedures, side effects are expected to be minimal. However specific side effects are not detailed in the provided information.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frailty development in older PC patients following prostate anti-androgen therapies initiation

Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation

Secondary study objectives

Activity level

Fatigue level

Hand-grip strength measured using hand-held dynamometer

+2 more

Other study objectives

Collecting and storing clinically-usable bio-measures

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (DWL)Experimental Treatment3 Interventions

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.

Group II: Arm I (BWL)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Actigraph

2005

Completed Phase 1

~1520

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