Trial Outcomes & Findings for The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer (NCT NCT01193530)

NCT ID: NCT01193530

Last Updated: 2019-03-26

Results Overview

Pittsburgh Sleep Quality Index (PSQI) measured at baseline and two weeks. The PSQI is a validated tool for insomnia, an effective instrument for measuring the quality and patterns of sleep using a 19-item questionnaire. It differentiates "poor" from "good" sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. Each area is rated from 0-3 with the higher score reflecting more severe sleep complaints. The addition of all scores permits the analysis of the participant's overall sleep experience. The PSQI global score ranges from 0 to 21, with a score of 5 or greater indicating significant sleep disturbance.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Baseline and Day 14

Results posted on

2019-03-26

Participant Flow

Recruitment Period: June 16, 2011 to February 08, 2012. All recruitment done at The University of Texas MD Anderson.

Study was halted early due to low accrual, many prospective participants did not meet inclusion and exclusion criteria.

Participant milestones

Participant milestones
Measure	Bright Light Therapy Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.	Dim Red Light Therapy Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
Overall Study STARTED	4	8
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Bright Light Therapy Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.	Dim Red Light Therapy Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
Overall Study Withdrawal by Subject	2	2
Overall Study Began Contraindicated Therapy	1	0
Overall Study Lost Light Box	0	1
Overall Study Returned home - out of state	0	1
Overall Study Non-Compliance	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bright Light Therapy n=4 Participants Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.	Dim Red Light Therapy n=8 Participants Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.	Total n=12 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	49 years n=7 Participants	50 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 14

Population: Due to low enrollment and participation data was not collected for analysis.

Outcome measures

Outcome data not reported

Adverse Events

Bright Light Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dim Red Light Therapy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Rony Dev, DO/Associate Professor, Palliative Care Medicine

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-6085

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Bright Light Therapy n=4 participants at risk Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods.	Dim Red Light Therapy n=8 participants at risk Daily Dim Red Light Therapy (placebo) using control Red Light Litebook device for 14 days then proceed to the open label phase and receive daily bright light for 14 days.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	25.0% 2/8 • Number of events 2 • Adverse events were collected for 14 days of treatment.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	37.5% 3/8 • Number of events 3 • Adverse events were collected for 14 days of treatment.
Psychiatric disorders Anxiety	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	50.0% 4/8 • Number of events 4 • Adverse events were collected for 14 days of treatment.
Gastrointestinal disorders Constipation	50.0% 2/4 • Number of events 2 • Adverse events were collected for 14 days of treatment.	37.5% 3/8 • Number of events 3 • Adverse events were collected for 14 days of treatment.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Nervous system disorders Depressed level of consciousness	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	37.5% 3/8 • Number of events 3 • Adverse events were collected for 14 days of treatment.
Psychiatric disorders Depression	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	75.0% 6/8 • Number of events 6 • Adverse events were collected for 14 days of treatment.
Gastrointestinal disorders Diarrhea	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	0.00% 0/8 • Adverse events were collected for 14 days of treatment.
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	25.0% 2/8 • Number of events 2 • Adverse events were collected for 14 days of treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 2/4 • Number of events 2 • Adverse events were collected for 14 days of treatment.	0.00% 0/8 • Adverse events were collected for 14 days of treatment.
Reproductive system and breast disorders Erectile dysfunction	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Eye disorders Eye pain	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	25.0% 2/8 • Number of events 2 • Adverse events were collected for 14 days of treatment.
General disorders Fatigue	75.0% 3/4 • Number of events 3 • Adverse events were collected for 14 days of treatment.	75.0% 6/8 • Number of events 6 • Adverse events were collected for 14 days of treatment.
Eye disorders Flashing vision	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Nervous system disorders Headache	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	37.5% 3/8 • Number of events 3 • Adverse events were collected for 14 days of treatment.
Reproductive system and breast disorders Hot flashes	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	0.00% 0/8 • Adverse events were collected for 14 days of treatment.
Vascular disorders Hypertension	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	25.0% 2/8 • Number of events 2 • Adverse events were collected for 14 days of treatment.
Endocrine disorders Hypothyroidism	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Psychiatric disorders Insomnia	75.0% 3/4 • Number of events 3 • Adverse events were collected for 14 days of treatment.	62.5% 5/8 • Number of events 5 • Adverse events were collected for 14 days of treatment.
Gastrointestinal disorders Mucositis oral	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	25.0% 2/8 • Number of events 2 • Adverse events were collected for 14 days of treatment.
Gastrointestinal disorders Nausea	50.0% 2/4 • Number of events 2 • Adverse events were collected for 14 days of treatment.	62.5% 5/8 • Number of events 5 • Adverse events were collected for 14 days of treatment.
Eye disorders Ocular/Visual (Other)	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
General disorders Pain	75.0% 3/4 • Number of events 3 • Adverse events were collected for 14 days of treatment.	75.0% 6/8 • Number of events 6 • Adverse events were collected for 14 days of treatment.
Nervous system disorders Seizure	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Investigations Serum triglyceride increased	25.0% 1/4 • Number of events 1 • Adverse events were collected for 14 days of treatment.	0.00% 0/8 • Adverse events were collected for 14 days of treatment.
Skin and subcutaneous tissue disorders Skin infection	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Vascular disorders Vascular Changes	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.
Gastrointestinal disorders Vomiting	50.0% 2/4 • Number of events 2 • Adverse events were collected for 14 days of treatment.	62.5% 5/8 • Number of events 5 • Adverse events were collected for 14 days of treatment.
Eye disorders Watering eyes	0.00% 0/4 • Adverse events were collected for 14 days of treatment.	12.5% 1/8 • Number of events 1 • Adverse events were collected for 14 days of treatment.