The "PC-LIGHT" Study

NCT ID: NCT03419585

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer Sleep Depression Fatigue Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Participants will be randomized to one of two arms: an intervention light group or a comparison light group. Both the participant and the investigator will be blind to the light assignment.

Study Groups

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Intervention light

30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).

Group Type EXPERIMENTAL

Intervention systematic light exposure

Intervention Type DEVICE

30 minutes of intervention systematic light exposure daily

Comparison light

30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).

Group Type ACTIVE_COMPARATOR

Comparison systematic light exposure

Intervention Type DEVICE

30 minutes of comparison systematic light exposure daily

Interventions

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Intervention systematic light exposure

30 minutes of intervention systematic light exposure daily

Intervention Type DEVICE

Comparison systematic light exposure

30 minutes of comparison systematic light exposure daily

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Lisa M. Wu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa M Wu, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Univeristy Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00205260

Identifier Type: -

Identifier Source: org_study_id

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