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The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer

NCT01193530 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-03-26

Study results available
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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.

Conditions

Interventions

OTHER

Bright Light Therapy

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.

OTHER

Dim Red Light Therapy

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.

BEHAVIORAL

Questionnaires

Weekly

BEHAVIORAL

Study Diaries

Daily logs

DEVICE

Red Light Litebook

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.

DEVICE

Bright Light Litebook

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Rony Dev, DO · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193530 on ClinicalTrials.gov