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Bright White Light Therapy for Prostate Cancer
Phase 2
Recruiting
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 baseline to 3 months post adt combination treatment initiation
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if bright white light (BWL) therapy can reduce fatigue & depression in prostate cancer patients on ADT therapy, potentially improving quality of life & cancer control.
Who is the study for?
Men over 60 with advanced prostate cancer, eligible for ADT combination therapy, and not currently on other investigational drugs. They should have a life expectancy of at least 18 months, no severe psychological impairments or night shift work, and no recent eye surgery or light sensitivity issues. Participants must be stable with controlled illnesses and without brain metastases or severe sleep disorders.
What is being tested?
The trial is testing if Bright White Light (BWL) Therapy can reduce fatigue and depression in men undergoing ADT combination therapy for advanced prostate cancer. It involves using bright white light to regulate sleep-wake cycles and potentially improve mood by increasing serotonin levels.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the brightness of the light, disruption of sleep patterns if improperly timed, mild eye strain, headache or nausea. Severe side effects are unlikely given the non-invasive nature of BWL therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months post adt combination treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months post adt combination treatment initiation
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in patient-reported fatigue
Secondary study objectives
Difference in geriatric assessments
Difference in mood outcomes
Difference in overall quality of life
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: Group II (Delayed BWL therapy)Experimental Treatment5 Interventions
Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.
Group II: Group I (Immediate BWL therapy)Experimental Treatment4 Interventions
Patients wear AYOpro BWL therapy glasses starting on day 1 of SOC ADT combination therapy for 12 months on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bright White Light Therapy
2020
N/A
~80
Combination Drug Therapy
2015
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,370 Total Patients Enrolled
8 Trials studying Prostate Cancer
2,151 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,795 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
William DalePrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
473 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used light therapy for fatigue or depression.My prostate cancer is rapidly worsening, and I may have less than 18 months to live.My prostate cancer diagnosis was confirmed through lab tests.I have recovered from side effects of previous cancer treatments, except for hair loss.I do not have brain metastases from prostate cancer.My heart is healthy enough for this trial, meeting the NYHA class 2B or better.My prostate cancer is of the small cell type.I do not have severe eye conditions that affect my vision.I have uncontrolled pain from my prostate cancer or another long-term illness.I have a severe sleep disorder like narcolepsy.I am recovering from an eye surgery that happened within the last 6 months and it's causing irritation.I am HIV positive, on treatment, and my viral load is undetectable.I have another active cancer besides the one being treated.I am 60 years old or older.I can switch hormonal treatments but must stop if my cancer worsens.My hepatitis B virus load is undetectable with treatment.I have another cancer type, but it won't affect this trial's treatment.I have previously been treated with specific hormone therapies before starting a new one.I've had bone problems due to prostate cancer in the last 6 months.I can take care of myself but might not be able to do heavy physical work.I have a tumor or cancer spread that can be measured by scans.My kidney function is within the safe range for the trial.I am eligible for specific prostate cancer treatments and may have had hormone therapy or surgery to remove my testicles.I am receiving docetaxel and my prostate cancer is not expected to worsen within 12 months.I had hepatitis C but am cured, or I'm being treated with no detectable virus.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (Immediate BWL therapy)
- Group 2: Group II (Delayed BWL therapy)
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.
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