Actively Recruiting
Phase 2 Study of Bright White Light Therapy During ADT Combination Treatment in Men With Advanced Prostate Cancer to Preserve Physical and Mental Health (SHINE)
Led by City of Hope Medical Center · Updated on 2025-10-06
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how bright white light (BWL) therapy may help reduce cancer-related fatigue and depression in men with advanced prostate cancer undergoing antiandrogen therapy (ADT) combination treatments. This phase II trial focuses on patients whose cancer has spread locally or to distant parts of the body. Since ADT combination therapy lowers testosterone to slow tumor growth but can worsen fatigue and depression, BWL therapy aims to support circadian rhythms and mood during treatment. Participants are randomly assigned to one of two groups. One group starts wearing AYOpro bright white light therapy glasses immediately on day 1 of their ADT combination therapy for 12 months. The other group begins the same BWL therapy 6 months after starting ADT combination therapy and continues for 6 months. The ADT combination treatment includes ADT with chemotherapy and androgen receptor targeted therapy or ADT with androgen receptor targeted therapies alone. During the 52-week study, participants will complete questionnaires assessing fatigue, mood, geriatric health, and overall quality of life. Researchers will monitor patient-reported fatigue changes after 3 months of treatment as the primary outcome. Secondary outcomes include mood, geriatric assessments, and quality of life changes over the same period. Safety and treatment adherence will be tracked throughout, with follow-up continuing for 4 weeks after stopping therapy or until death.
CONDITIONS
Brief Title
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed prostate cancer
- Radiographic evidence of measurable or metastatic prostate cancer
- Eligible for ADT plus chemotherapy and hormonal therapy or ADT plus hormonal therapy
- Age 60 years or older
- ECOG performance status of 2 or less
- Expected time to next treatment of 12 months or more and life expectancy of 18 months or more
- Leukocytes count 3,000/mcL or above
- Absolute neutrophil count 1,500/mcL or above
- Platelets count 100,000/mcL or above
- Total bilirubin within normal institutional limits
- AST/ALT levels less than or equal to 3 times institutional upper limit
- Creatinine within normal limits or GFR 50 mL/min/1.73 m² or above
- HIV positive participants on effective therapy with undetectable viral load within 6 months
- Controlled hepatitis B or cured hepatitis C infection
- Prior or concurrent malignancies not interfering with study
- Cardiac function New York Heart Association class 2B or better
- Ability and willingness to sign informed consent
- May continue if hormonal treatment changes but not if discontinued due to cancer progression
You will not qualify if you...
- Metastatic castration-resistant prostate cancer if receiving docetaxel
- Unresolved toxicities over grade 1 from prior anti-cancer therapy except alopecia
- Prior combination hormonal therapy with certain agents if planned for same agents
- Receiving other investigational agents
- Brain metastases
- Allergic reactions to similar compounds
- Small cell prostate cancer histology
- Recent symptomatic skeletal events within 6 months
- Uncontrolled pain
- Visceral crisis with life expectancy under 18 months
- Uncontrolled illnesses
- Second active malignancy
- Severe sleep disorders like narcolepsy
- Eye diseases limiting light processing
- Severe psychological disorders
- Night shift work employment
- Prior use of light therapy for fatigue or depression
- Recent eye surgery causing irritation
- Sensitivity to light, epilepsy, or seizure history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive standard of care ADT combination therapy and wear bright white light therapy glasses either starting immediately or delayed by 6 months, continuing on trial for up to 12 months.
Visits according to treatment schedule over 12 months
Duration - Up to 52 weeks
Participants are followed for up to 52 weeks after starting therapy or for 4 weeks after stopping protocol therapy or until death, whichever occurs first.
Follow-up visits for up to 4 weeks after treatment ends
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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