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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Activity level
Fatigue level
Hand-grip strength measured using hand-held dynamometer
+2 moreOther outcome measures
Collecting and storing clinically-usable bio-measures
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
N/A
~1440
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,696 Total Patients Enrolled
563 Trials studying Prostate Cancer
509,031 Patients Enrolled for Prostate Cancer
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,583 Total Patients Enrolled
13 Trials studying Prostate Cancer
5,580 Patients Enrolled for Prostate Cancer
William DalePrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
650 Total Patients Enrolled
2 Trials studying Prostate Cancer
434 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have very serious problems with sleeping.You have an eye condition that affects how well you can see.You currently have an uncontrolled illness or an ongoing infection.You have a serious mental health condition that may affect your ability to participate in the study.You have used light therapy before to treat fatigue or depression.You are expected to live for at least 6 more months.You have severe medical conditions that make you weak and vulnerable.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (BWL)
- Group 2: Arm II (DWL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for individuals to participate in this research?
"This investigation, which was initially published on September 24th 2018 and last modified on May 10th 2022 is no longer accepting patients. However, there are currently 1466 other trials in need of participants."
Answered by AI
What are the chief goals of this experiment?
"This medical trial, conducted over a 6-month period, aims to assess frailty in elderly prostate cancer patients post initiation of anti-androgen therapy. Secondary objectives include evaluating fatigue levels via the FACIT-Fatigue scale, hand grip strength with a handheld dynamometer, and IADLs with a repeated measures mixed linear model."
Answered by AI
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