Actively Recruiting
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
Led by City of Hope Medical Center · Updated on 2025-10-06
210
Participants Needed
1
Research Sites
229 weeks
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
This phase II trial tests how well bright white light (BWL) therapy works in reducing cancer-related fatigue and depression in patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment with antiandrogen therapy (ADT) combination therapy. Combination treatment including ADT plus chemotherapy and androgen receptor (AR) targeted therapy or ADT plus AR targeted therapies work by reducing testosterone. Most prostate tumor cells rely on testosterone to help them grow; therefore, ADT combination therapy causes prostate tumor cells to die or to grow more slowly leading to improved overall survival in men with advanced prostate cancer when compared with ADT alone. However, lower levels of testosterone is also commonly associated with worsening fatigue and depression. If prolonged and severe, these complications can alter patient treatment plans, impacting not just quality of life, but leading to inadequate cancer control. BWL therapy is a type of phototherapy that utilizes bright white full-spectrum light, either through a light box or light therapy glasses to help regulate circadian rhythms. Circadian rhythms are physical, mental, and behavioral changes that follow a 24-hour cycle, including the sleep-wake cycle which can become disrupted in cancer patients undergoing treatment, leading to increased fatigue. Additionally, exposure to bright light may increase the production of serotonin, a neurotransmitter that is associated with mood regulation. BWL therapy with AYOpro light therapy glasses may serve as a supportive care measure for men with advanced prostate to help reduce fatigue, as well as improve mood and overall quality of life during ADT combination therapy to maintain cancer care without suffering complications of therapy.
CONDITIONS
Official 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 disease or metastatic lesions confirmed by CT, MRI, bone scan, Axumin, or PSMA-PET scan
- Eligible for ADT plus docetaxel (up to 6 cycles) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy)
- Age 60 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Expected time to next treatment of at least 12 months and life expectancy of at least 18 months
- Leukocytes count of at least 3,000/mcL
- Absolute neutrophil count of at least 1,500/mcL
- Platelet count of at least 100,000/mcL
- Total bilirubin at or below institutional upper limit of normal (ULN)
- AST/ALT at or below 3 times institutional ULN
- Creatinine at or below institutional ULN or glomerular filtration rate (GFR) of at least 50 mL/min/1.73 m2 (minimum 30 mL/min/1.73 m2 if supported by safety data)
- HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months
- Participants with chronic hepatitis B infection must have undetectable viral load on suppressive therapy if needed
- Participants with hepatitis C infection must be treated and cured or have undetectable viral load if currently treated
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessments
- Participants with cardiac disease history should have New York Heart Association Functional Classification class 2B or better
- Ability and willingness to sign informed consent
- Participants discontinuing baseline hormonal treatment may continue if switching to eligible treatments and not due to cancer progression
You will not qualify if you...
- Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer with expected median time to next therapy under 12 months
- Unrecovered adverse events from prior anti-cancer therapy above grade 1 except alopecia
- Prior treatment with combination hormonal therapy including abiraterone acetate, enzalutamide, apalutamide, or darolutamide if planning to start the same treatments
- Receiving any other investigational agents
- Presence of brain metastases
- History of allergic reactions to similar compounds used in this study
- Histologic evidence of small cell prostate cancer
- Symptomatic skeletal events such as cord compression, fracture, or recent radiation/surgery to bone lesion within 6 months
- Uncontrolled pain related to prostate cancer or other chronic conditions
- Visceral crisis with rapidly progressive disease and life expectancy under 18 months
- Uncontrolled intercurrent illnesses
- Concurrent second active malignancy
- Severe sleep disorders like narcolepsy
- Eye diseases that limit light processing (untreated cataracts, glaucoma, macular degeneration, blindness, pupil dilation issues, retinal disorders)
- Severe psychological impairments such as bipolar disorder or manic episodes
- Current employment in night shift work
- Previous use of light therapy for fatigue or depression
- Recovery period less than 6 months from eye surgery causing irritation
- Sensitivity to light, epilepsy, or history of seizures
AI-Screening
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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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