Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy

Prostate Carcinoma Clinical Trial

Official title:

Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03661437
• Other study ID #: 18140
• Secondary ID: NCI-2018-0186818
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 24, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: December 31, 2024
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 60 Years and older

Eligibility

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.

• A life expectancy of 6 months or longer.

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

Exclusion Criteria:

• Significant pre-existing frailty precluding completion of baseline assessments.

• Other active malignancies

• Previous use of radiation therapy within the year prior to consent.

• Widely metastatic disease.

• Confounding serious medical illnesses which causes frailty.

• Severe sleep disorders.

• Eye diseases which limit the ability of light to be processed.

• Severe psychological impairment.

• Current employment in night shift work.

• Previous use of light therapy to alleviate fatigue or depressive symptoms.

• Secondary cancer diagnosis within the past 5 years.

• Plans to travel across meridians during treatment.

• Uncontrolled illness including ongoing or active infection in disease status patients.

Related Conditions & MeSH terms

• Frailty
• Prostate Carcinoma

Intervention

Device:
• Actigraph
Wear Actiwatch

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Systematic Light Exposure
Undergo BWL treatment
• Systematic Light Exposure
Receive DWL treatment

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Collecting and storing clinically-usable bio-measures	Blood samples and saliva swaps will be collected for future analysis.	Baseline up to 6 months
Primary	Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation	Will be assessed using Short Physical Performance Battery (SPPB). Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
Primary	Frailty development in older PC patients following prostate anti-androgen therapies initiation	Will be assessed using SPPB. Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
Secondary	Fatigue level	Will be measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
Secondary	Physical performance	Will be assessed by measuring the waist and hip circumference using a fabric measuring tape to determine the circumference of the waist (centered at the umbilicus) and hip (centered on the greater trochanter). Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
Secondary	Hand-grip strength measured using hand-held dynamometer	Muscle weakness will be measured by grip strength. Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
Secondary	Instrumental activities of daily living (IADL) scale	Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
Secondary	Activity level	Activity counts will be recorded with the Actiwatch Spectrum Plus for five days at each time-point. Will be evaluated using a repeated measures mixed linear model.	Up to 6 months