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

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+