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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01193530
Recruitment Status : Terminated (Low Accrual)
First Posted : September 2, 2010
Last Update Posted : May 27, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Advanced Cancers Device: Bright Light Therapy Device Device: Dim Red Light Therapy Device Behavioral: Questionnaires Behavioral: Study Diaries Phase 2 Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
Study Start Date : June 2011
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Bright Light Therapy Device: Bright Light Therapy Device
30 minutes every day for 14 days.
Behavioral: Questionnaires
Weekly
Other Name: Survey
Behavioral: Study Diaries
Daily logs
Other Name: journal
Placebo Comparator: Dim Red Light Therapy
After 14 days, Placebo Red Light group will begin receiving light therapy for another 14 days.
Device: Dim Red Light Therapy Device
Initially 30 minutes every day for 14 days where red light device accounts for placebo.
Behavioral: Questionnaires
Weekly
Other Name: Survey
Behavioral: Study Diaries
Daily logs
Other Name: journal


Outcome Measures

Primary Outcome Measures :
  1. Effect of Light Therapy on Sleep Disturbances [ Time Frame: 2 weeks ]
    Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Age 18 or greater
  3. Karnofsky performance status score of >=40 at time of inclusion into study
  4. Agrees to return to MD Anderson Cancer Center (MDACC) for follow-up visits
  5. English speaking

Exclusion Criteria:

  1. Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
  2. Patients with a history of retinal disease
  3. Patients with a current diagnosis of major depression disorder or generalized anxiety disorder
  4. Patients who have received light therapy in the past either as part of treatment for other disorders or as a study subject
  5. Patients currently on amiodarone, thiazide diuretics or epidermal growth factor receptor (EGFR) inhibitors (erlotinib, gefitinib, cetuximab, panitumumab)
  6. Patients who are currently receiving ultraviolet A light/ultraviolet B light (UVA/UVB) therapy or tanning sessions at salons
  7. Patients with a diagnosis of obstructive sleep apnea or narcolepsy
  8. Patients with >2 hours of direct exposure to outdoor natural light per day (light exposure diary -- screening).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193530


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Rony Dev, DO M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01193530     History of Changes
Other Study ID Numbers: 2009-0738
NCI-2012-01793 ( Registry Identifier: NCI CTRP )
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 2016

Keywords provided by M.D. Anderson Cancer Center:
Sleep Disturbances
Depression
Anxiety
Fatigue
Quality of life

Additional relevant MeSH terms:
Neoplasms
Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms