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

NCT03661437 | Completed Early Phase 1 FDA Drug

• 2 other identifiers: 18140NCI-2018-01868
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Fatigue level

  Up to 6 months

• Physical performance

  Up to 6 months

• Hand-grip strength measured using hand-held dynamometer

  Up to 6 months

• Instrumental activities of daily living (IADL) scale

  Up to 6 months

• Activity level

  Up to 6 months

Other Outcomes (1)

• Collecting and storing clinically-usable bio-measures

  Baseline up to 6 months

Study Arms (2)

Arm I (BWL)

EXPERIMENTAL

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.

Device: Actigraph; Other: Questionnaire Administration; Procedure: Systematic Light Exposure

Arm II (DWL)

EXPERIMENTAL

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.

Device: Actigraph; Other: Questionnaire Administration; Procedure: Systematic Light Exposure

Interventions

Actigraph DEVICE

Wear Actiwatch

Also known as: Actigram

Arm I (BWL); Arm II (DWL)

Questionnaire Administration OTHER

Ancillary studies

Arm I (BWL); Arm II (DWL)

Systematic Light Exposure PROCEDURE

Undergo BWL treatment

Also known as: sLE

Arm I (BWL)

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• William Dale

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: September 24, 2018
• Primary Completion: July 10, 2020
• Study Completion: March 24, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (1)