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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01868 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 18140 | Other Identifier | City of Hope Medical Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actigraph | Device | Wear Actiwatch |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Dale | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Questionnaire Administration | Other | Ancillary studies |
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| Systematic Light Exposure | Procedure | Undergo BWL treatment |
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| Systematic Light Exposure | Procedure | Receive DWL treatment |
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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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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