drugset / Trial / NCT05474846

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

NCT05474846

Phase 2/3 Recruiting 188 enrolled M.D. Anderson Cancer Center
RandomizedSingle-groupSingle-blindTreatment

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.

Timeline

Start
2022-11-21
Primary completion
2027-02-28
Completion
2027-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule Oral
Subject Methylphenidate Small molecule Oral