Bright White Light Therapy for Fatigue and Depression in Advanced Prostate Cancer
This study is investigating if bright white light (BWL) therapy can help reduce fatigue and depression in men with advanced prostate cancer. These men are also receiving antiandrogen therapy (ADT) combination treatment, which works by lowering testosterone to slow cancer growth. The study aims to see if using AYOpro BWL therapy glasses from the start of ADT combination treatment helps more than starting it later. Researchers will measure changes in fatigue, mood, and overall quality of life. You may be eligible if you are a man aged 60 or older with confirmed advanced prostate cancer that can be measured on scans. The study plans to enroll 210 participants.
- Study design
- This is an interventional study, but the phase is not specified. Participants will be randomly assigned to one of two groups.
- What's involved
- Participants in one group will wear AYOpro BWL therapy glasses for 12 months. All participants will receive standard ADT combination therapy, and there will be quality-of-life assessments and questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes in fatigue up to 3 months after starting ADT combination treatment.
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NCT05869682
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
Recruiting
PHASE2Ages 60+InterventionalSupportive careCity of Hope Medical CenterInvestigator-initiated
~210 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:Bright White Light TherapyCombination Drug TherapyElectronic Health Record ReviewQuality-of-Life AssessmentQuestionnaire Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in patient-reported fatigue
Measured over Baseline to 3 months post antiandrogen therapy (ADT) combination treatment initiation
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- William Dale · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants must have histologically or cytologically confirmed prostate cancer
Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 10 mm ( \>= 1 cm) with computed tomography (CT) scan or magnetic resonance imaging (MRI), or metastatic lesions as identified as related to prostate cancer on a standard technetium bone scan. Alternatively patients may have radiographic evidence of metastatic disease on an Axumin or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) scan
Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy). Prior use of ADT with a gonadotropin hormone-releasing hormone (GnRH) agonist or antagonist, or prior orchiectomy is allowed
Age \>= 60 years
Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
Expected time to next treatment of \>= 12 months and life expectancy of \>= 18 months, as determined by a study Investigator
Leukocytes \>= 3,000/mcL
Absolute neutrophil count \>= 1,500/mcL
Platelets \>= 100,000/mcL
Total bilirubin =\< institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN
Creatinine =\< institutional ULN OR
Glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2
Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better
Ability to understand and the willingness to sign a written informed consent document
Participants are still eligible and may proceed with the protocol and bright white light therapy if they discontinue baseline hormonal treatment, but plan to continue with another of the eligible treatments. However, if they discontinue treatment due to cancer progression, they should not continue on the protocol
Exclusion
Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next therapy is \< 12 months
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or darolutamide
Participants who are receiving any other investigational agents
Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain
History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study
Histologic evidence of small cell prostate cancer
Symptomatic skeletal event complication of prostate cancer such as cord compression, fracture, or need for radiation or surgery to a bone lesion within 6 months
Uncontrolled pain related to prostate cancer or separate chronic condition
Visceral crisis from prostate cancer suggesting rapidly progressive disease and life expectancy of \< 18 months
Participants with uncontrolled intercurrent illness
Concurrent second active malignancy
Severe sleep disorders (e.g. Narcolepsy)
Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder)
Severe psychological impairment (e.g., bipolar disorder or manic episodes)
Current employment in night shift work
Previous use of light therapy to alleviate fatigue or depressive symptoms
Currently recovering from previous eye surgery within the past 6 months that causes eye irritation
Sensitivity to light, epilepsy, or a history of seizures
What this trial measures
- Change in patient-reported fatigueBaseline to 3 months post antiandrogen therapy (ADT) combination treatment initiation
Will compare patient-reported fatigue between men treated with immediate versus delayed bright white light (BWL) therapy during ADT combination treatment (ADT + chemotherapy + hormonal intensification OR ADT+ hormonal intensification). Measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument. T test will be used to compare FACIT-Fatigue change score between two arms (T2 \[3 month after treatment initiation\] minus T1 \[before or at treatment initiation\]).