Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy

NCT05869682 | Recruiting Phase 2 DMC FDA Device

• 3 other identifiers: 22628NCI-2023-03486P30CA033572
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Carcinoma; Stage III Prostate Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Change in patient-reported fatigue

  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 \[before or at treatment initiation\]).

  Baseline to 3 months post antiandrogen therapy (ADT) combination treatment initiation

Secondary Outcomes (3)

• Difference in mood outcomes

  Baseline to 3 months post ADT combination treatment initiation

• Difference in geriatric assessments

  Baseline to 3 months post ADT combination treatment initiation

• Difference in overall quality of life

  Baseline to 3 months post ADT combination treatment initiation

Study Arms (2)

Group I (Immediate BWL therapy)

EXPERIMENTAL

Patients wear AYOpro BWL therapy glasses starting on day 1 of SOC ADT combination therapy for 12 months on trial.

Procedure: Bright White Light Therapy; Drug: Combination Drug Therapy; Other: Electronic Health Record Review; Other: Questionnaire Administration

Group II (Delayed BWL therapy)

EXPERIMENTAL

Patients wear AYOpro BWL therapy glasses starting 6 months after the start of SOC ADT combination therapy for 6 months on trial.

Procedure: Bright White Light Therapy; Drug: Combination Drug Therapy; Other: Electronic Health Record Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Bright White Light Therapy PROCEDURE

Wear AYOpro BWL therapy

Also known as: Bright Light Therapy, Bright White Light, BWL

Group I (Immediate BWL therapy); Group II (Delayed BWL therapy)

Combination Drug Therapy DRUG

Receive SOC ADT combination therapy

Also known as: Drug Therapy, Combination

Group I (Immediate BWL therapy); Group II (Delayed BWL therapy)

Electronic Health Record Review OTHER

Ancillary studies

Group I (Immediate BWL therapy); Group II (Delayed BWL therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group II (Delayed BWL therapy)

Questionnaire Administration OTHER

Ancillary studies

Group I (Immediate BWL therapy); Group II (Delayed BWL therapy)

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultraviolet Therapy; Drug Therapy, Combination

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Drug Therapy

Study Officials

• William Dale

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, only the designated study team member knows the participant's allocation. Oncologists or clinical research associates collecting data are not informed of patient allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 22, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)