Light Exposure to Prevent Frailty in Prostate Cancer Patients

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: City of Hope Medical Center

Must be taking: Androgen deprivation therapy

Disqualifiers: Other malignancies, Metastatic disease, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether systemic light exposure can prevent frailty in older men with prostate cancer undergoing hormone therapy. Hormone therapy often causes weakness, fatigue, and reduced activity. The study tests two light exposure methods using special glasses, with participants wearing them for 30 minutes each morning over several months. Men with prostate cancer who are beginning hormone treatment and have no major health issues may be suitable candidates for this study. As an Early Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to explore this innovative approach.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants will be on hormonal therapy for prostate cancer, so you may need to continue those treatments.

What prior data suggests that systemic light exposure is safe for preventing frailty in prostate cancer patients?

Research has shown that bright light therapy is generally easy to use and has few side effects. For older men with prostate cancer, bright white light may help reduce tiredness and muscle weakness caused by hormone therapy. Although the safety of this light treatment is still under study, early results suggest it is a safe option for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about light exposure for preventing frailty in prostate cancer patients because it offers a non-invasive and easy-to-use option that differs from traditional treatments like medications or physical therapies. This approach uses Luminette glasses to deliver bright white light (BWL) or dim white light (DWL) daily, potentially boosting patients' energy and mood by regulating their circadian rhythms. Unlike standard treatments, which often rely on pharmaceuticals with potential side effects, light therapy focuses on harnessing natural processes to improve well-being, which could make it a safer and more appealing option for many patients.

What evidence suggests that systemic light exposure might be an effective treatment for preventing frailty in prostate cancer patients?

Research has shown that bright white light (BWL) therapy, which participants in this trial may receive, might lessen the negative effects of hormone treatment in older men with prostate cancer. These effects include fatigue and muscle weakness. Studies suggest that BWL can reduce tiredness and feelings of depression in these patients. Exposure to bright white light may increase energy levels and reduce exhaustion. Although still in early stages, the hope is that this light therapy could improve the overall quality of life for those weakened by their treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

William Dale

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for older prostate cancer patients starting hormone therapy with minimal disease burden, who can sign consent and have a life expectancy of 6 months or more. It's not for those with severe sleep disorders, eye diseases affecting light processing, psychological impairments, night shift workers, recent secondary cancers, plans to travel across time zones during treatment, uncontrolled illnesses or infections.

Inclusion Criteria

Prostate cancer (PC) patients who are starting androgen deprivation therapy (ADT), abiraterone, or enzalutamide with plans to continue for at least six months with minimal evidence of disease burden in accordance with current standards of care.

All subjects must have the ability to understand and the willingness to sign a written or electronic informed consent.

You are expected to live for at least 6 more months.

Exclusion Criteria

You have very serious problems with sleeping.

You have an eye condition that affects how well you can see.

Current employment in night shift work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

Treatment

Participants undergo bright white light (BWL) or dim white light (DWL) treatment using Luminette glasses for 30 minutes every morning

3-6 months

3 visits (in-person) at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Systemic Light Exposure

Trial Overview The study tests if systematic light exposure prevents frailty symptoms caused by hormone therapy in older men with prostate cancer. Frailty includes fatigue, slow walking speed, reduced activity levels, muscle loss and weakness. The trial involves questionnaires and actigraphy (movement monitoring) to assess the effects.

How Is the Trial Designed?

Group I: Arm II (DWL) Experimental Treatment 3 Interventions

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.

Group II: Arm I (BWL) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. withpower.com withpower.com/trial/phase-prostatic-neoplasms-8-2018-30288

Light Exposure to Prevent Frailty in Prostate Cancer Patients This pilot trial studies how well systemic light exposure works in preventing frailty in older patients with prostate cancer on hormonal therapy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03419585

Study Details | NCT03419585 | The "PC-LIGHT" Study The proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation ...

3. onclive.com onclive.com/view/bright-white-light-may-offset-negative-effects-of-adt-in-older-men-with-prostate-cancer

Bright White Light May Offset Negative Effects of ADT in ... For older patients with prostate cancer, bright white light could potentially mitigate the negative effects of androgen deprivation therapy ...

4. dana-farber.org dana-farber.org/clinical-trials/24-332

A Phase 2 Study of Bright White Light During Treatment ... 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 ...

5. allclinicaltrials.com allclinicaltrials.com/study/NCT05869682

Bright White Light Therapy in Reducing Cancer-Related ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2873563/

Life course sun exposure and risk of prostate cancer Our data and meta-analyses provide limited support for the hypothesis that increased exposure to sunlight may reduce prostate cancer risk.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425005901

Effectiveness and Safety of Bright Light Therapy in ... Bright light therapy is considered a well-tolerated and easy to administer form of treatment with relatively low costs. Our systematic review is focused on the ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11311462/

Exposure to Light at Night and Risk of Cancer A link between LAN exposure and increased risk for lung cancers, leukemias, and hepatocarcinomas in mice models has already been established, ...