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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Device: Actigraph; Procedure: Systematic Light Exposure; Procedure: Systematic Light Exposure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Device: Actigraph; Wear Actiwatch; Other Names: Actigram; Procedure: Systematic Light Exposure; Undergo BWL treatment; Other Names: sLE; Procedure: Systematic Light Exposure; Receive DWL treatment; Other Names: sLE
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Device: Actigraph; Wear Actiwatch; Other Names: Actigram; Procedure: Systematic Light Exposure; Undergo BWL treatment; Other Names: sLE; Procedure: Systematic Light Exposure; Receive DWL treatment; Other Names: sLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Instrumental activities of daily living (IADL) scale	Will be evaluated using a repeated measures mixed linear model.	Up to 6 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collecting and storing clinically-usable bio-measures	Blood samples and saliva swaps will be collected for future analysis.	Baseline up to 6 months

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: William Dale, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Actual): July 10, 2020
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 18140 (Other Identifier: City of Hope Comprehensive Cancer Center); NCI-2018-01868 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No