We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Low Accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01193530
First Posted: September 2, 2010
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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 Intervention Phase
Advanced Cancers Device: Bright Light Therapy Device Device: Dim Red Light Therapy Device Behavioral: Questionnaires Behavioral: Study Diaries Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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


Enrollment: 12
Study Start Date: June 2011
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: August 31, 2010
First Posted: September 2, 2010
Last Update Posted: October 12, 2017
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