The "PC-LIGHT" Study

NCT03419585 | Completed

• 1 other identifier: STU00205260
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Sleep; Depression; Fatigue; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Fatigue FACIT-Fatigue scores

  FACIT-Fatigue scores

  Baseline

• Fatigue

  FACIT-Fatigue scores

  Change from Baseline to the 4th week of the intervention

• Fatigue

  FACIT-Fatigue scores

  Change from Baseline to the 8th week of the intervention

• Fatigue

  FACIT-Fatigue scores

  Change from Baseline to 2 months after the intervention

Secondary Outcomes (27)

• Circadian activity rhythms

  Baseline

• Circadian activity rhythms

  During the 4th week of the intervention

• Circadian activity rhythms

  During the 8th week of the intervention

• Circadian activity rhythms

  2 months after the intervention

• Sleep quality

  Baseline

Other Outcomes (6)

• Credibility/Expectancy

  Baseline

• Treatment satisfaction

  During the 8th week of the intervention

• Usage of light box

  Throughout intervention period (8 weeks)

Study Arms (2)

Intervention light

EXPERIMENTAL

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

Device: Intervention systematic light exposure

Comparison light

ACTIVE COMPARATOR

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

Device: Comparison systematic light exposure

Interventions

Intervention systematic light exposure DEVICE

30 minutes of intervention systematic light exposure daily

Intervention light

Comparison systematic light exposure DEVICE

30 minutes of comparison systematic light exposure daily

Comparison light

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Univeristy Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Depression; Fatigue

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa M Wu, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 5, 2018
• Study Start: December 12, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)