Melatonin for Sleep
Phase 2 & 3
Recruiting
Led By Sriram Yennu, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
presence of poor sleep quality, defined as Pittsburgh Sleep Quality Index (PSQI) total score ≥ 5, with patients describing poor sleep as being present for a minimum of 2 weeks;
no pain or stable pain (defined as pain ≤ 4 on Edmonton Symptom Assessment Scale (ESAS) or under control and on stable doses of opioids for 1 month).
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough the study completion, an average of 1 year.
Awards & highlights
Study Summary
This trial is testing if CBT, combined with either BLT, Methylphenidate, and/or Melatonin, can help improve sleep and other related symptoms in cancer patients.
Eligible Conditions
- Sleep
- Fatigue
- Anxiety
- Cancer
- Depression
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been experiencing poor sleep quality for at least 2 weeks and your score on a sleep quality questionnaire is 5 or higher.
Select...
You do not have severe or unstable pain. If you are taking pain medication, it must be at a consistent dose for at least one month.
Select...
You have been experiencing poor sleep for at least 2 weeks, as indicated by a score of 5 or higher on the Pittsburgh Sleep Quality Index (PSQI).
Select...
You don't have severe or uncontrolled pain. If you do have pain, it should be manageable with medication and not getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through the study completion, an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through the study completion, an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pittsburgh Sleep Quality Index (PSQI) questionnaires
Side effects data
From 2014 Phase 2 trial • 40 Patients • NCT0111437342%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Dizziness
11%
Nausea
11%
Weakness
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: Placebo (CLT+ placebo MT + placebo MP with CBT)Experimental Treatment2 Interventions
Patients receive placebo Melatonin (called placebo MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Group II: Methylphenidate (CLT + placebo MT + MP with CBT)Experimental Treatment1 Intervention
Patients receive Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks, placebo Melatonin (called placebo MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Group III: Combination Therapy (BLT+MT+MP with CBT)Experimental Treatment3 Interventions
Patients receive Melatonin (called MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Group IV: Bright light and Melatonin (BLT + MT+ placebo MP with CBT)Experimental Treatment2 Interventions
Patients receive Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, Melatonin (called MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
2014
Completed Phase 4
~431850
Melatonin
2014
Completed Phase 4
~1150
Find a site
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,885 Previous Clinical Trials
1,781,011 Total Patients Enrolled
1 Trials studying Sleep
700 Patients Enrolled for Sleep
Sriram Yennu, MDPrincipal Investigator
MD Anderson1 Previous Clinical Trials
110 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current vacancies in this clinical trial for patients seeking treatment?
"This study, which was first posted on December 1st, 2022 is no longer recruiting patients for participation. The most recent update to the posting was on August 23rd, 2022. There are 2,300 other trials seeking participants."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
Texas
How old are they?
18 - 65
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Havanese William wible I took other drugs none of them ever work so I'm looking to get us a shot I believe it can help me. So if you pick my name I really appreciate it and give me a chance also please pay for my flight if I get accepted to go to Texas so I got to pay for that myself just wondering thank you 1-267-596-6291.
Patient
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