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Study details
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Combination Therapy for Sleep Disturbance in Patients With Advanced Cancer

M.D. Anderson Cancer Center
NCT IDNCT05474846ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2/3

Target enrollment

188

Study length

about 4.3 years

Ages

18+

Locations

1 site in TX

What this study is about

This trial is testing if a combination of treatments, including melatonin, methylphenidate, and/or bright light therapy (BLT), can improve sleep and related symptoms like fatigue, anxiety, and depression in people with advanced cancer. This is an investigational trial comparing these treatments to placebos.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Placebo for Melatonin
  • 2.Take Melatonin
  • 3.Take Methylphenidate

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
OralOral

How treatment is administered

Treatment Assignment
All receive treatment

Everyone gets the investigational treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

melatonin (Hormone supplement; regulates sleep-wake cycle), methylphenidate (CNS stimulant; blocks reuptake of dopamine and norepinephrine)

Drug routes

oral (Disintegrating Oral Tablet)

Endpoints

Primary: Pittsburgh Sleep Quality Index (PSQI) questionnaires

Body systems

Psychiatry / Mental Health, Oncology