The "PC-LIGHT" Study

Not Applicable

Completed

• Conditions: Fatigue; Depression; Quality of Life; Prostate Cancer; Sleep
• Interventions: Device: Comparison systematic light exposure; Device: Intervention systematic light exposure

• Registration Number: NCT03419585
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Study Start: 2018-12-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 75

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison light	Comparison systematic light exposure	30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).
Intervention light	Intervention systematic light exposure	30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).

Primary Outcome Measures

Name	Time	Method
Fatigue FACIT-Fatigue scores	Baseline	FACIT-Fatigue scores
Fatigue	Change from Baseline to 2 months after the intervention	FACIT-Fatigue scores

Secondary Outcome Measures

Name	Time	Method
Sleep quality	2 months after the intervention	Pittsburgh Sleep Quality Index (PSQI)
Cognitive functioning	2 months after the intervention	Neuropsychological tests
Sexual and urinary functioning	2 months after the intervention	3 items from the Sexual Adjustment Questionnaire \& 3 items from American Urological Association (AUA) symptom index
Health-related quality of life	2 months after the intervention	Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: "The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being."with prostate cancer patients (1, 2, 3). It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.
Circadian activity rhythms	2 months after the intervention	Actigraphy
Depressed mood	2 months after the intervention	Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Cognitive Functioning	2 months after the intervention	Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)

Trial Locations

Locations (1)

Northwestern Univeristy Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States