Using bright white light therapy to reduce fatigue and depression in advanced prostate cancer patients

Phase 2 Study of Bright White Light During Treatment With ADT Combination Therapy in Men With Advanced Prostate Cancer to PreServe PHysIcal and MeNtal HEalth (SHINE)

This study is testing if bright white light therapy can help reduce fatigue and depression in men with advanced prostate cancer who are receiving treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 60 Years and up
• Sex: Male
• Sponsor: City of Hope Medical Center (other)
• Drugs / interventions: radiation, prednisone, chemotherapy
• Locations: 1 site (Duarte, California)
• Trial ID: NCT05869682 on ClinicalTrials.gov

What this trial studies

This phase II trial evaluates the effectiveness of bright white light (BWL) therapy in alleviating cancer-related fatigue and depression among patients with advanced prostate cancer undergoing antiandrogen therapy. Participants are randomized into two groups: one receiving immediate BWL therapy alongside their treatment and the other starting BWL therapy after a six-month delay. The study measures patient-reported fatigue, mood, geriatric assessments, and overall quality of life over a 52-week period. The goal is to determine if immediate BWL therapy can significantly improve these outcomes compared to delayed therapy.

Who should consider this trial

Good fit: Ideal candidates are men with histologically confirmed advanced prostate cancer who are eligible for combination antiandrogen therapy.

Not a fit: Patients with non-measurable disease or those not undergoing antiandrogen therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly enhance the quality of life for patients suffering from fatigue and depression related to advanced prostate cancer treatments.

How similar studies have performed: While the use of light therapy in cancer care is not widely tested, similar approaches have shown promise in managing fatigue and mood disorders in other patient populations.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Duarte, California

• City of Hope Medical Center — Duarte, California, United States (RECRUITING)

Study contacts

• Principal investigator: William Dale — City of Hope Medical Center

Conditions: Advanced Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8