Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy
Primary Purpose
Prostate Carcinoma
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Actigraph
Questionnaire Administration
Systematic Light Exposure
Systematic Light Exposure
Sponsored by

About this trial
This is an interventional supportive care trial for Prostate Carcinoma
Eligibility Criteria
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.
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I (BWL)
Arm II (DWL)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Instrumental activities of daily living (IADL) scale
Will be evaluated using a repeated measures mixed linear model.
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.
Full Information
NCT ID
NCT03661437
First Posted
September 5, 2018
Last Updated
May 15, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03661437
Brief Title
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy
Official Title
Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
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
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (BWL)
Arm Type
Experimental
Arm Description
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 Title
Arm II (DWL)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Actigraph
Other Intervention Name(s)
Actigram
Intervention Description
Wear Actiwatch
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Systematic Light Exposure
Other Intervention Name(s)
sLE
Intervention Description
Undergo BWL treatment
Intervention Type
Procedure
Intervention Name(s)
Systematic Light Exposure
Other Intervention Name(s)
sLE
Intervention Description
Receive DWL treatment
Primary Outcome Measure Information:
Title
Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation
Description
Will be assessed using Short Physical Performance Battery (SPPB). Will be evaluated using a repeated measures mixed linear model.
Time Frame
Up to 6 months
Title
Frailty development in older PC patients following prostate anti-androgen therapies initiation
Description
Will be assessed using SPPB. Will be evaluated using a repeated measures mixed linear model.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Fatigue level
Description
Will be measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue. Will be evaluated using a repeated measures mixed linear model.
Time Frame
Up to 6 months
Title
Physical performance
Description
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.
Time Frame
Up to 6 months
Title
Hand-grip strength measured using hand-held dynamometer
Description
Muscle weakness will be measured by grip strength. Will be evaluated using a repeated measures mixed linear model.
Time Frame
Up to 6 months
Title
Instrumental activities of daily living (IADL) scale
Description
Will be evaluated using a repeated measures mixed linear model.
Time Frame
Up to 6 months
Title
Activity level
Description
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.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Collecting and storing clinically-usable bio-measures
Description
Blood samples and saliva swaps will be collected for future analysis.
Time Frame
Baseline up to 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Dale
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy
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