Clinical trial NCT03419585: The "PC-LIGHT" Study
Official title: Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Sleep
Depression
Fatigue
Quality of Life
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation therapy and will investigate how it works. This study would facilitate the development of this potential preventative treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related fatigue.


Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with clinical localized prostate cancer,
* Are about to begin external beam radiation therapy (RT) for prostate cancer,
* Are 18 years of age or older,
* Are able to speak or read English,
* Have internet access.

Exclusion Criteria:

* History of light therapy use (e.g. systematic light exposure),
* Active infection
* History of chronic fatigue disorders
* Confounding underlying medical illnesses such as significant pre-existing anemia (Hb\<10 gm/dl)
* Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment)
* Hypothyroidism or documented history of hypothyroidism on thyroid replacement hormone within \<3 months of initiating RT
* History of bipolar disorder or mania
* History of seasonal affective disorder
* Diagnosed sleep apnea, restless legs, or other sleep disorders (not including insomnia) known to affect fatigue
* Use of photosensitizing medication
* Plans to travel across more than 2 time zones during the study
* Shift worker
* Adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners will be excluded from the study

Primary outcomes:
measure: Fatigue FACIT-Fatigue scores
timeFrame: Baseline
measure: Fatigue
timeFrame: Change from Baseline to the 4th week of the intervention
measure: Fatigue
timeFrame: Change from Baseline to the 8th week of the intervention
measure: Fatigue
timeFrame: Change from Baseline to 2 months after the intervention
Secondary outcomes:
measure: Circadian activity rhythms
timeFrame: Baseline
measure: Circadian activity rhythms
timeFrame: During the 4th week of the intervention
measure: Circadian activity rhythms
timeFrame: During the 8th week of the intervention
measure: Circadian activity rhythms
timeFrame: 2 months after the intervention
measure: Sleep quality
timeFrame: Baseline
measure: Sleep quality
timeFrame: During the 4th week of the intervention
measure: Sleep quality
timeFrame: During the 8th week of the intervention
measure: Sleep quality
timeFrame: 2 months after the intervention
measure: Depressed mood
timeFrame: Baseline
measure: Depressed mood
timeFrame: During the 4th week of the intervention
measure: Depressed mood
timeFrame: During the 8th week of the intervention
measure: Depressed mood
timeFrame: 2 months after the intervention
measure: Cognitive Functioning
timeFrame: Baseline
measure: Cognitive Functioning
timeFrame: During the 4th week of the intervention
measure: Cognitive Functioning
timeFrame: During the 8th week of the intervention
measure: Cognitive Functioning
timeFrame: 2 months after the intervention
measure: Sexual and urinary functioning
timeFrame: Baseline
measure: Sexual and urinary functioning
timeFrame: During the 4th week of the intervention
measure: Sexual and urinary functioning
timeFrame: During the 8th week of the intervention
measure: Sexual and urinary functioning
timeFrame: 2 months after the intervention
measure: Cognitive functioning
timeFrame: Baseline
measure: Cognitive functioning
timeFrame: During the 8th week of the intervention
measure: Cognitive functioning
timeFrame: 2 months after the intervention
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: During the 4th week of the intervention
measure: Health-related quality of life
timeFrame: During the 8th week of the intervention
measure: Health-related quality of life
timeFrame: 2 months after the intervention
Other outcomes:
measure: Credibility/Expectancy
timeFrame: Baseline
measure: Treatment satisfaction
timeFrame: During the 8th week of the intervention
measure: Usage of light box
timeFrame: Throughout intervention period (8 weeks)
measure: Chronotype
timeFrame: Baseline
measure: BMI
timeFrame: Baseline
measure: Physical health
timeFrame: Baseline
Locations:
city: Chicago
country: United States
facility: Northwestern Univeristy Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Lisa M Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: