RecruitingPhase 2Phase 3NCT05474846

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

188 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination therapy approach — including cognitive behavioral therapy (CBT) and other supportive treatments — to help people with advanced cancer who are experiencing significant sleep problems. **You may be eligible if...** - You have advanced cancer and have been experiencing poor sleep quality for at least 2 weeks (Pittsburgh Sleep Quality Index score of 5 or higher) - You are 18 or older and are cognitively able to answer questions and participate in therapy - You have a life expectancy of at least 1 year as assessed by your oncologist - You have stable or no significant pain - You are able to complete visits in person or via telemedicine in Texas **You may NOT be eligible if...** - You have a known psychiatric illness (schizophrenia, bipolar disorder, major depression) or a pre-existing sleep disorder (sleep apnea, narcolepsy) - You are on systemic anti-inflammatory medications like steroids - You have severe vision problems (glaucoma, significant cataracts, or blindness) - You are unable to communicate in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMelatonin

Given by PO

OTHERPlacebo for Melatonin

Given by PO

DRUGMelatonin

Given by PO

DRUGMethylphenidate

Given by PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05474846


Related Trials