Systemic Light Exposure in Preventing Frailty in Older Participants With Prostate Cancer on Hormonal Therapy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 65 - 99 |
| Updated: | 10/10/2018 |
| Start Date: | September 24, 2018 |
| End Date: | April 14, 2019 |
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 participants 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 participants.
older participants 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 participants.
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.
III. Examine the feasibility of collecting and storing clinically-usable bio-measures for
future analysis in patients at baseline and at 6 months, including blood samples
(inflammatory markers), and salivary swaps (genetics, genomics, cortisol circadian rhythms).
(Exploratory)
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (BWL): Participants wear an Actiwatch for 5 days at baseline, 3 months and 6 months.
Beginning 1-3 weeks after first anti-androgen therapy, participants undergo BWL treatment
using Luminette glasses for 30 minutes every morning for 6 months.
ARM II (DWL): Participants wear an Actiwatch for 5 days at baseline, 3 months and 6 months.
Beginning 1-3 weeks after first anti-androgen therapy, participants undergo DWL treatment
using Luminette glasses for 30 minutes every morning for 6 months.
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.
III. Examine the feasibility of collecting and storing clinically-usable bio-measures for
future analysis in patients at baseline and at 6 months, including blood samples
(inflammatory markers), and salivary swaps (genetics, genomics, cortisol circadian rhythms).
(Exploratory)
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (BWL): Participants wear an Actiwatch for 5 days at baseline, 3 months and 6 months.
Beginning 1-3 weeks after first anti-androgen therapy, participants undergo BWL treatment
using Luminette glasses for 30 minutes every morning for 6 months.
ARM II (DWL): Participants wear an Actiwatch for 5 days at baseline, 3 months and 6 months.
Beginning 1-3 weeks after first anti-androgen therapy, participants undergo DWL treatment
using Luminette glasses for 30 minutes every morning for 6 months.
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.
Exclusion Criteria:
- Significant pre-existing frailty precluding completion of baseline assessments.
- Other active malignancies
- Previous use of radiation therapy.
- 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.
We found this trial at
1
site
Duarte, California 91010
Principal Investigator: William Dale, MD, PhD
Phone: 626-218-5153
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