Clinical trial NCT01193530: The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
Official title: The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Advanced Cancers
Keywords: Sleep Disturbances
Depression
Anxiety
Fatigue
Quality of life
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to one of two groups:

* Group 1 will receive one type of light therapy for 30 minutes every day for 14 days.
* Group 2 will receive a placebo light for 30 minutes every day for 14 days. The placebo light is not designed to have any effect on your sleep.

You will not know which group you are in. After 14 days, both groups will begin receiving the light therapy for another 14 days.

Litebook:

You will use a device called a Litebook to receive either the light therapy or the placebo light for 30 minutes, within 2 hours of waking up every day. The Litebook is about the size of a deck of cards. To use the Litebook, you will place it on a table within 2 feet of you while you are sitting down. The Litebook will either deliver the light therapy or the placebo light. You do not need to look directly into the Litebook and you can do usual activities such as eating or reading while you are using it. The study staff will teach you how to use the Litebook.

Study Diaries:

You will complete the following diaries at the end of each day of the 28-day study period:

* The light exposure diary about how much light you were exposed to.
* The sleep diary about your sleeping habits.

It should take about 5 minutes each day to make entries in the study diaries. You will return the diaries to the study staff at 2 weeks and 4 weeks.

You will also wear a watch that will measure your activity level for 24 hours a day while you are on study. You will return the watch to the study staff after you have completed the study.

Questionnaires:

You will complete a questionnaire about any symptoms you are having from the light therapy at the beginning of the study, at 1 week, at 2 weeks, and at 4 weeks. The questionnaire at 1 week can be done over the phone. It should take about 5 minutes to complete.

You will complete the following questionnaires at the beginning of the study, at 2 weeks, and at 4 weeks:

* The Edmonton Symptom Assessment Scale. You will rate 10 symptoms such as tiredness, shortness of breath, pain, and nausea.
* The FACIT-F questionnaire about how well you are able to perform the normal activities of daily living, your quality of life, and how tired you are.
* The HADS questionnaire about your mood.
* The Pittsburgh Sleep Quality Index about your sleep quality, how long you sleep, and any difficulties you are having when you are trying to sleep.

It should take about 25 minutes to complete all of the questionnaires.

Length of Study:

You will be on study for 28 days.

This is an investigational study. The use of light therapy in patients with difficulty sleeping is investigational. It is currently being used for research purposes only.

Up to 152 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility 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).

Primary outcomes:
measure: Effect of Bright Light Therapy on Sleep Disturbances Compared to Dim Red Light in Patients With Advanced Cancer Followed at a Palliative Care Outpatient Clinic at a Comprehensive Cancer Center
timeFrame: Baseline and Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Rony Dev, DO
role: PRINCIPAL_INVESTIGATOR
References: