Prostate Carcinoma Clinical Trial
Official title:
Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT
This pilot trial studies how well systemic light exposure works in preventing frailty in older patients with prostate cancer on hormonal therapy. Hormone therapy causes many symptoms of frailty in older men including fatigue, slower time to walk a specified distance, reduced activity levels, loss of lean muscle, and muscle weakness. It is not yet known if systemic light exposure may reduce frailty in older prostate cancer patients.
PRIMARY OBJECTIVES: I. Determine if bright white light (BWL), compared to dim white light (DWL), significantly prevents frailty development in older prostate cancer (PC) patients following prostate anti-androgen therapy initiation. II. Determine if BWL, compared to DWL, significantly increases functional performance and physical activity levels, yields significant reductions in fatigue, lowers body mass index (BMI), and reduces weakness in older PC patients following prostate anti-androgen therapy initiation. EXPLORATORY OBJECTIVE: I. Examine the feasibility of collecting and storing clinically-usable bio-measures for future analysis in patients at baseline and if available at 6 months, including blood samples (inflammatory markers), and salivary swabs (genetics, genomics, cortisol circadian rhythms). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (BWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo BWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months. ARM II (DWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo DWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04457232 -
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation
|
Phase 1 | |
| Completed |
NCT02337465 -
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer
|
N/A | |
| Completed |
NCT03013413 -
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
|
N/A | |
| Recruiting |
NCT06037863 -
Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial
|
N/A | |
| Active, not recruiting |
NCT03580499 -
Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy
|
N/A | |
| Completed |
NCT03326440 -
Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer
|
N/A | |
| Recruiting |
NCT04597359 -
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
|
Phase 2 | |
| Active, not recruiting |
NCT03263650 -
Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC
|
Phase 2 | |
| Active, not recruiting |
NCT04600336 -
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04299620 -
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
|
N/A | |
| Completed |
NCT04976257 -
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion
|
Early Phase 1 | |
| Completed |
NCT02957981 -
The Genetic Education for Men Trial: Web-Based Education vs. Standard Care
|
N/A | |
| Withdrawn |
NCT03408561 -
Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer
|
N/A | |
| Enrolling by invitation |
NCT06347809 -
DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
|
||
| Enrolling by invitation |
NCT04254133 -
Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
|
||
| Recruiting |
NCT05519878 -
Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers
|
N/A | |
| Recruiting |
NCT02994758 -
Development of Diagnostics and Treatment of Urological Cancers
|
N/A | |
| Completed |
NCT01497431 -
Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT00002540 -
Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)
|
N/A | |
| Completed |
NCT03101046 -
Treatment of Metastatic Castrate Resistant Prostate Cancer Patients According to Circulating Tumor Cells Kinetic
|
Phase 2 |