Skip to content
Study details
Enrolling now

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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Placebo for Melatonin
  • 2.Take Melatonin
  • 3.Take Methylphenidate
PhasePhase 2/Phase 3
DrugMelatonin
Routeoral
Primary goalPittsburgh Sleep Quality Index (PSQI) questionnaires

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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