Prostate CarcinomaEarly Phase 1NCT03661437
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy
A Early Phase 1 study testing Actigraph, Questionnaire Administration and Systematic Light Exposure in people with Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Actigraph, Questionnaire Administration and Systematic Light Exposure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 24 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Actigraph, Questionnaire Administration, Systematic Light Exposure
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphDevice
Also called Actigram
Wear Actiwatch
Questionnaire AdministrationOther
Ancillary studies
Systematic Light ExposureProcedure or surgery
Also called sLE
Undergo BWL treatment
Systematic Light ExposureProcedure or surgery
Also called sLE
Receive DWL treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Actigraph; Other: Questionnaire Administration; Procedure: Systematic Light Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Instrumental activities of daily living (IADL) scale
Will be evaluated using a repeated measures mixed linear model.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start24 Sep 2018
- Primary completion10 Jul 2020
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- William Dale, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661437
- Sponsor's protocol ID
- 18140
- Other IDs
- NCI-2018-01868, 18140
- Status last verified
- Apr 2025
- First submitted
- 5 Sep 2018
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy to Prevent Frailty in Older Men With Prostate Cancer on Hormonal Therapy: A Pilot RCT
- ClinicalTrials.gov ID
- NCT03661437
- Acronym / sponsor ID
- 18140
- Conditions
- Prostate Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (BWL) | Experimental | Device: Actigraph, Other: Questionnaire Administration, Procedure: Systematic Light ExposurePatients 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) | Experimental | Device: Actigraph, Other: Questionnaire Administration, Procedure: Systematic Light ExposurePatients 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 may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActigraphAlso: ActigramWear Actiwatch | Device | Arm I (BWL), Arm II (DWL) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (BWL), Arm II (DWL) |
| Systematic Light ExposureAlso: sLEUndergo BWL treatment | Procedure or surgery | Arm I (BWL) |
| Systematic Light ExposureAlso: sLEReceive DWL treatment | Procedure or surgery | Arm II (DWL) |
Primary outcome
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.
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.
5 secondary outcomes
Fatigue level
Time frame: Up to 6 months
Physical performance
Time frame: Up to 6 months
Hand-grip strength measured using hand-held dynamometer
Time frame: Up to 6 months
Instrumental activities of daily living (IADL) scale
Time frame: Up to 6 months
Activity level
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Dale principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Actigraph, Questionnaire Administration and Systematic Light Exposure in people with Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical performance in older prostate cancer (PC) patients following prostate anti-androgen therapies initiation (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.