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Sleep Therapies for Cancer-Related Sleep Disorders

Phase 2
Waitlist Available
Led By Sriram Yennu
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
Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone, mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in the study
Patients with no pain and with stable pain (defined as pain under control and on stable doses of opioids for 1 week) are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 45 days
Awards & highlights

Study Summary

This trial is studying how well two types of therapy work to treat sleep issues in people with cancer.

Who is the study for?
This trial is for cancer patients experiencing sleep disturbances, on stable pain control, and undergoing cancer therapy. They must have a certain level of physical functioning (Zubrod <= 2), controlled symptoms of pain and depression, normal organ function tests, and not be on excluded medications or have specific conditions like blindness or major psychiatric disorders.Check my eligibility
What is being tested?
The study is testing whether cognitive behavioral therapy combined with methylphenidate hydrochloride (a stimulant), therapeutic melatonin (a sleep aid), and light therapy can improve sleep quality, reduce fatigue, and enhance overall well-being in cancer patients with sleep issues.See study design
What are the potential side effects?
Potential side effects may include reactions to the stimulant such as increased heart rate or blood pressure, digestive changes due to melatonin use, eye strain from light therapy, and general discomfort that sometimes accompanies counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of certain medications like dexamethasone or zolpidem for 2 weeks.
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My pain is either nonexistent or under control with stable medication for the past week.
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My pain and depression, if any, have been stable for the last 2 weeks.
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I am currently undergoing cancer treatment and have trouble sleeping.
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I am mostly able to carry out my daily activities.
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I have finished more than a week of radiation or chemotherapy and my oncologist agrees I can join this study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 45 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 45 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pittsburgh Sleep Quality Index (PSQI) score
Secondary outcome measures
Change in Edmonton Symptom Assessment System (ESAS) scores
Change in Functional Assessment of Chronic Illness Therapy (FACIT)-F scores
Change in Hospital Anxiety Depression Scale (HADS) scores
+3 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Arm VIII (placebo, melatonin, sham light intervention, CBT)Experimental Treatment5 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Group II: Arm VII (methylphenidate, placebo, sham light therapy, CBT)Experimental Treatment5 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Group III: Arm VI (placebo, placebo, light therapy, CBT)Experimental Treatment4 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
Group IV: Arm V (placebo, melatonin, light therapy, CBT)Experimental Treatment5 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
Group V: Arm IV (methylphenidate, placebo, light therapy, CBT)Experimental Treatment5 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.
Group VI: Arm III (methylphenidate, melatonin, sham light therapy, CBT)Experimental Treatment5 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Group VII: Arm II (placebo, placebo, sham light therapy, CBT)Experimental Treatment4 Interventions
Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.
Group VIII: Arm I (methylphenidate, melatonin, light therapy, CBT)Experimental Treatment5 Interventions
Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phototherapy
2021
Completed Phase 4
~750
Methylphenidate Hydrochloride
2008
Completed Phase 4
~1610
Sham Intervention
2018
N/A
~820

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,284 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,096 Total Patients Enrolled
Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center
12 Previous Clinical Trials
1,489 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01628029 — Phase 2
Sleep Disorders Research Study Groups: Arm VIII (placebo, melatonin, sham light intervention, CBT), Arm V (placebo, melatonin, light therapy, CBT), Arm II (placebo, placebo, sham light therapy, CBT), Arm I (methylphenidate, melatonin, light therapy, CBT), Arm VII (methylphenidate, placebo, sham light therapy, CBT), Arm IV (methylphenidate, placebo, light therapy, CBT), Arm VI (placebo, placebo, light therapy, CBT), Arm III (methylphenidate, melatonin, sham light therapy, CBT)
Sleep Disorders Clinical Trial 2023: Cognitive Behavioral Therapy Highlights & Side Effects. Trial Name: NCT01628029 — Phase 2
Cognitive Behavioral Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01628029 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What benefits does the FDA see in Counseling?

"Counseling received a safety score of 2 from our team at Power. There is some data supporting safety, but none yet backing efficacy claims in Phase 2 trials."

Answered by AI

Can new patients join this trial right now?

"This clinical trial is not presently recruiting candidates at this time. The clinical trial was originally posted on 1/15/2014 and was last edited on 10/31/2022. If you are seeking for other studies, there are currently 2688 trials actively admitting patients with malignant solid neoplasms and 53 trials for Counseling actively looking for patients."

Answered by AI
~20 spots leftby Jun 2028