Sponsor:
M.D. Anderson Cancer Center
Code:
NCT05474846
Conditions
Sleep
Fatigue
Anxiety
Cancer
Depression
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Interventions
Melatonin
Placebo for Melatonin
Melatonin
Methylphenidate
Brief summary:
Conditions
Sleep
Fatigue
Anxiety
Cancer
Depression
Study ID
NCT05474846
Start date
Nov 21, 2022
Status verified date
Nov, 2025
Completion date
Feb 28, 2027
Anticipated
Primary completion date
Feb 28, 2027
Anticipated
Eligibility Criteria
Sex: All
Age: 18+
Healthy Volunteers: Not accepted
Enrollment
188 participants
Anticipated
Allocation
Randomized
Intervention Model
Single group
Primary purpose
Treatment
Arms
experimental: Combination Therapy (BLT+MT+MP with CBT)
experimental: Placebo (CLT+ placebo MT + placebo MP with CBT)
experimental: Bright light and Melatonin (BLT + MT+ placebo MP with CBT)
experimental: Methylphenidate (CLT + placebo MT + MP with CBT)
Interventions
Melatonin
Placebo for Melatonin
Melatonin
Methylphenidate
Primary outcome measure
Central contacts
Locations
MD Anderson Cancer Center
Recruiting
Houston, Texas, United States, 77030
Contacts
Sponsor
M.D. Anderson Cancer Center
Last update posted
Nov 6, 2025
Last verified
Nov, 2025
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2025-11-06.