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NCT05869682 · ClinicalTrials.gov registry record · Phase 2
Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy
A Phase 2 study of Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT05869682: Recruiting Phase 2 study of Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by City of Hope Medical Center.
NCT05869682 is a Phase 2 study of Prostate Carcinoma and Metastatic Prostate Carcinoma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 210 participants, below the 1,498-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05869682, a Phase 2 study of Prostate Carcinoma and Metastatic Prostate Carcinoma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 \[before or at treatment initiation\]).
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- OTHER Electronic Health Record Review
- PROCEDURE Bright White Light Therapy
- DRUG Combination Drug Therapy
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2024-07-09 |
| Est. Completion | 2028-11-30 |
| Phase | Phase 2 |
What NCT05869682 shows while recruiting
NCT05869682 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,498-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (86% lower).
The record links to 5 conditions, with Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05869682 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05869682 about?
NCT05869682 is a clinical study titled "Bright White Light Therapy in Reducing Cancer-Related Fatigue and Depression in Advanced Prostate Cancer Patients Undergoing Treatment With ADT Combination Therapy". 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 ...
What is the current status of trial NCT05869682?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2024-07-09. Estimated completion is 2028-11-30.
What conditions does trial NCT05869682 study?
This clinical trial studies the following conditions: Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Advanced Prostate Carcinoma.
What interventions are being tested in trial NCT05869682?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Electronic Health Record Review (OTHER), Bright White Light Therapy (PROCEDURE), Combination Drug Therapy (DRUG).
Who is sponsoring clinical trial NCT05869682?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05869682 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05869682's enrollment target sits among peer trials
210 17th of 59 higher than 43 of 59 other Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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