Advanced CancersPhase 2/3NCT01193530
The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
A Phase 2/3 study testing Bright Light Therapy, Dim Red Light Therapy and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Bright Light Therapy, Dim Red Light Therapy and Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Age 18 or greater
- Karnofsky performance status score of >=40 at time of inclusion into study
- Agrees to return to MD Anderson Cancer Center (MDACC) for follow-up visits
- English speaking
Who cannot join
- Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
- Patients with a history of retinal disease
- Patients with a current diagnosis of major depression disorder or generalized anxiety disorder
- Patients who have received light therapy in the past either as part of treatment for other disorders or as a study subject
- Patients currently on amiodarone, thiazide diuretics or epidermal growth factor receptor (EGFR) inhibitors (erlotinib, gefitinib, cetuximab, panitumumab)
- Patients who are currently receiving ultraviolet A light/ultraviolet B light (UVA/UVB) therapy or tanning sessions at salons
- Patients with a diagnosis of obstructive sleep apnea or narcolepsy
- Patients with >2 hours of direct exposure to outdoor natural light per day (light exposure diary -- screening).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Advanced Cancers
- Being tested
- Bright Light Therapy, Dim Red Light Therapy, Questionnaires, Study Diaries, Red Light Litebook
- Keywords
- Sleep Disturbances, Depression, Anxiety, Fatigue, Quality of life
- Medical subject headings
- Parasomnias, Depression, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright Light TherapyOther
30 minutes every day for 14 days. After enrollment on day 0, blinded phase of study intervention (i.e. daily bright light or red light) from day 1 to day 14+/-3, then proceed to the open label phase and receive daily bright light between day 15+/-3 and day 28+/-3.
Dim Red Light TherapyOther
From day 1 to day 14+/-3, daily dim red light therapy for 30 minutes for 14 days where red light device accounts for placebo of the blinded phase of study intervention, then between day 15+/-3 and day 28+/-3 open label phase with daily bright light.
QuestionnairesBehavioural
Also called Survey
Weekly
Study DiariesBehavioural
Also called journal
Daily logs
Red Light LitebookDevice
Control red light device produced by Litebook identical in appearance and dimensions to the bright light device, with the exception it emits at wavelength 680nm (i.e. red light) and at an intensity of 50 lux.
Bright Light LitebookDevice
Bright light device consists of 60 LEDs with spectral emission peak at approximately 464nm and fluorescent phosphors which provide a broader, secondary spectral peak near 564nm. Collectively the emitted light appears white.
| Study group | Role | What they receive |
|---|---|---|
| Bright Light Therapy | Experimental | Daily Bright Light Therapy using Bright Light Litebook device for two 14 day periods. Receives: Other: Bright Light Therapy; Behavioral: Questionnaires; Behavioral: Study Diaries; Device: Bright Light Litebook |
| Dim Red Light Therapy | Placebo comparator | 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. Receives: Other: Dim Red Light Therapy; Behavioral: Questionnaires; Behavioral: Study Diaries; Device: Red Light Litebook |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startJun 2011
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Low Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rony Dev, DO, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193530
- Sponsor's protocol ID
- 2009-0738
- Other IDs
- NCI-2012-01793
- Status last verified
- Mar 2019
- First submitted
- 31 Aug 2010
- Last updated
- 26 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Light Therapy for Managing Sleep Disturbances in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01193530
- Acronym / sponsor ID
- 2009-0738
- Conditions
- Advanced Cancers
- Keywords
- Sleep Disturbances, Depression, Anxiety, Fatigue, Quality of life
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Sep 2010 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright Light Therapy | Experimental | Other: Bright Light Therapy, Behavioral: Questionnaires, Behavioral: Study Diaries, Device: Bright Light LitebookDaily Bright Light Therapy using Bright Light Litebook device for two 14 day periods. |
| Dim Red Light Therapy | Placebo comparator | Other: Dim Red Light Therapy, Behavioral: Questionnaires, Behavioral: Study Diaries, Device: Red Light LitebookDaily 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Age 18 or greater
- Karnofsky performance status score of >=40 at time of inclusion into study
- Agrees to return to MD Anderson Cancer Center (MDACC) for follow-up visits
- English speaking
Key exclusion criteria (8 listed)
- Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
- Patients with a history of retinal disease
- Patients with a current diagnosis of major depression disorder or generalized anxiety disorder
- Patients who have received light therapy in the past either as part of treatment for other disorders or as a study subject
- Patients currently on amiodarone, thiazide diuretics or epidermal growth factor receptor (EGFR) inhibitors (erlotinib, gefitinib, cetuximab, panitumumab)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright Light Therapy30 minutes every day for 14 days. After enrollment on day 0, blinded phase of study intervention (i.e. daily bright light or red light) from day 1 to day 14+/-3, then proceed to the open label phase and receive daily bright light between day 15+/-3 and day 28+/-3. | Other | Bright Light Therapy |
| Dim Red Light TherapyFrom day 1 to day 14+/-3, daily dim red light therapy for 30 minutes for 14 days where red light device accounts for placebo of the blinded phase of study intervention, then between day 15+/-3 and day 28+/-3 open label phase with daily bright light. | Other | Dim Red Light Therapy |
| QuestionnairesAlso: SurveyWeekly | Behavioural | Bright Light Therapy, Dim Red Light Therapy |
| Study DiariesAlso: journalDaily logs | Behavioural | Bright Light Therapy, Dim Red Light Therapy |
| Red Light LitebookControl red light device produced by Litebook identical in appearance and dimensions to the bright light device, with the exception it emits at wavelength 680nm (i.e. red light) and at an intensity of 50 lux. | Device | Dim Red Light Therapy |
| Bright Light LitebookBright light device consists of 60 LEDs with spectral emission peak at approximately 464nm and fluorescent phosphors which provide a broader, secondary spectral peak near 564nm. Collectively the emitted light appears white. | Device | Bright Light Therapy |
Primary outcome
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
Time frame: Baseline and Day 14
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rony Dev, DO principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bright Light Therapy, Dim Red Light Therapy and Questionnaires in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.