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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01193530
First received: August 31, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks.


Estimated Enrollment: 152
Study Start Date: June 2011
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 EGFR inhibitors (erlotinib, gefitinib, cetuximab, panitumumab)
  6. Patients who are currently receiving 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193530

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

Additional Information:
UT MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01193530     History of Changes
Other Study ID Numbers: 2009-0738
Study First Received: August 31, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013