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Combination Therapy for Sleep Disturbance in Cancer

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 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.

Who is the study for?

This trial is for English-speaking cancer patients with sleep issues, stable or no pain, and a life expectancy of over a year. They must be cognitively able to participate and not have severe psychiatric illnesses, certain sleep disorders, or be on specific medications that could interfere with the study.Check my eligibility

What is being tested?

The study tests if Cognitive Behavior Therapy (CBT) combined with Bright Light Therapy (BLT), methylphenidate, melatonin, or their placebos can improve sleep quality and reduce fatigue, anxiety, and depression in advanced cancer patients.See study design

What are the potential side effects?

Potential side effects may include daytime drowsiness from melatonin; increased heart rate, blood pressure changes from methylphenidate; eye strain or headache from BLT; plus general risks associated with CBT like emotional discomfort.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the study completion, an average of 1 year. for reporting.

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 • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

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

Melatonin

2014

Completed Phase 4

~1150

Methylphenidate

2014

Completed Phase 4

~431850

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,288 Total Patients Enrolled

1 Trials studying Sleep

88 Patients Enrolled for Sleep

Sriram Yennu, MDPrincipal InvestigatorMD Anderson

2 Previous Clinical Trials

350 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?

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.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer

2022. "Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05474846.

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