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Completed

NCT Number: NCT03661437

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

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.

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Key information

Age range

60 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Actigraph

Device

Wear Actiwatch

Other names: Actigram

Questionnaire Administration

Other

Ancillary studies

Systematic Light Exposure

Procedure

Undergo BWL treatment

Other names: sLE

Primary outcomes

  1. Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation

    Time frame: Up to 6 months

    Will be assessed using Short Physical Performance Battery (SPPB). Will be evaluated using a repeated measures mixed linear model.

  2. Frailty development in older PC patients following prostate anti-androgen therapies initiation

    Time frame: Up to 6 months

    Will be assessed using SPPB. Will be evaluated using a repeated measures mixed linear model.

Secondary outcomes

  1. Fatigue level

    Time frame: Up to 6 months

    Will be measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Will be evaluated using a repeated measures mixed linear model.

  2. Physical performance

    Time frame: Up to 6 months

    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.

  3. Hand-grip strength measured using hand-held dynamometer

    Time frame: Up to 6 months

    Muscle weakness will be measured by grip strength. Will be evaluated using a repeated measures mixed linear model.

  4. Instrumental activities of daily living (IADL) scale

    Time frame: Up to 6 months

    Will be evaluated using a repeated measures mixed linear model.

  5. Activity level

    Time frame: Up to 6 months

    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.

Other outcomes

  1. Collecting and storing clinically-usable bio-measures

    Time frame: Baseline up to 6 months

    Blood samples and saliva swaps will be collected for future analysis.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Sep 7, 2018
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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