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, 2014
Last verified: February 2014
  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:


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 2015 (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
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, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01193530     History of Changes
Other Study ID Numbers: 2009-0738, NCI-2012-01793
Study First Received: August 31, 2010
Last Updated: February 12, 2014
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 August 28, 2014