Improving Sleep in Advanced Cancer Patients

This study is looking at whether Cognitive Behavioral Therapy (CBT), a type of talk therapy, combined with either bright light therapy, methylphenidate (a medication), and/or melatonin (a natural hormone), can help improve sleep and related issues like fatigue, anxiety, and depression in people with advanced cancer. You might be able to join if you are 18 or older, have been experiencing poor sleep for at least two weeks (a PSQI score of 5 or higher), can communicate in English, and are cognitively able to answer questions. The main goal is to see if these combinations improve sleep quality, measured by questionnaires, over about a year. The study status is currently unclear.

Study design
This interventional study plans to enroll 188 participants. It compares different active treatments (melatonin, methylphenidate, and bright light therapy) and their combinations against placebo (an inactive substance).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your sleep quality will be assessed at the end of 6 weeks, and then again at 3 and 6 months after the intervention, with an average follow-up of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05474846

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~188 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:MelatoninPlacebo for MelatoninMethylphenidate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pittsburgh Sleep Quality Index (PSQI) questionnaires
Measured over Through the study completion, an average of 1 year.
Sleep
Fatigue
Anxiety
Cancer
Depression
1 sites across 1 states
Texas1
  • Sriram Yennu, MD · PRINCIPAL_INVESTIGATOR · MD Anderson

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  • Pittsburgh Sleep Quality Index (PSQI) questionnairesThrough the study completion, an average of 1 year.

    Pittsburgh Sleep Quality Index (PSQI) questionnaire score on a 4-point scale ranging from 0 (not during the 2 weeks) to 3 (3 or more times a week).