Study Stopped
Low Accrual
The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
2 other identifiers
interventional
12
1 country
1
Brief Summary
The goal of this research study is to learn if a type of light therapy can be used to help patients with advanced cancer who are having difficulty sleeping to sleep better.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2011
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2010
CompletedFirst Posted
Study publicly available on registry
September 2, 2010
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedMarch 26, 2019
March 1, 2019
4.8 years
August 31, 2010
March 31, 2017
March 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center
Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks. The PSQI is a validated tool for insomnia, an effective instrument for measuring the quality and patterns of sleep using a 19-item questionnaire. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The addition of all scores permits the analysis of the participant's overall sleep experience. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance.
Baseline and Day 14
Study Arms (2)
Bright Light Therapy
EXPERIMENTALDaily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.
Dim Red Light Therapy
PLACEBO COMPARATORDaily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
Interventions
30 minutes every day for 14 days. After enrollment on day 0, blinded phase of study intervention (i.e. daily bright light or red light) from day 1 to day 14+/-3, then proceed to the open label phase and receive daily bright light between day 15+/-3 and day 28+/-3.
From day 1 to day 14+/-3, daily dim red light therapy for 30 minutes for 14 days where red light device accounts for placebo of the blinded phase of study intervention, then between day 15+/-3 and day 28+/-3 open label phase with daily bright light.
Control red light device produced by Litebook identical in appearance and dimensions to the bright light device, with the exception it emits at wavelength 680nm (i.e. red light) and at an intensity of 50 lux.
Bright light device consists of 60 LEDs with spectral emission peak at approximately 464nm and fluorescent phosphors which provide a broader, secondary spectral peak near 564nm. Collectively the emitted light appears white.
Eligibility Criteria
You may qualify if:
- Advanced cancer patients seen in Supportive Care outpatient clinic at M.D. Anderson Cancer Center, with average sleep disturbance \>=4 out of 10 for at least one week
- Age 18 or greater
- Agrees to return to MD Anderson Cancer Center (MDACC) for follow-up visits
- English speaking
You may not qualify if:
- Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
- Patients with a history of retinal disease
- Patients with a current diagnosis of major depression disorder or generalized anxiety disorder
- Patients who have received light therapy in the past either as part of treatment for other disorders or as a study subject
- Patients currently on amiodarone, thiazide diuretics or epidermal growth factor receptor (EGFR) inhibitors (erlotinib, gefitinib, cetuximab, panitumumab)
- Patients who are currently receiving ultraviolet A light/ultraviolet B light (UVA/UVB) therapy or tanning sessions at salons
- Patients with a diagnosis of obstructive sleep apnea or narcolepsy
- Patients with \>2 hours of direct exposure to outdoor natural light per day (light exposure diary -- screening).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rony Dev, DO/Associate Professor, Palliative Care Medicine
- Organization
- The University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Rony Dev, DO
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2010
First Posted
September 2, 2010
Study Start
June 1, 2011
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 26, 2019
Results First Posted
March 26, 2019
Record last verified: 2019-03