Actively Recruiting
Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer
Led by M.D. Anderson Cancer Center · Updated on 2025-11-06
188
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Poor sleep quality with PSQI score of 5 or higher lasting at least 2 weeks
- Ability to communicate in English
- Cognitively able to respond to questions (Memorial Delirium Assessment Scale score of 13 or less)
- Willing and able to sign written informed consent
- Life expectancy of 1 year or more as judged by oncologist or investigator
- No pain or stable pain with score of 4 or less on Edmonton Symptom Assessment Scale and stable opioid doses for 1 month
- Age 18 years or older
- Willing to complete follow-up visits and CBT intervention either in person or virtually within Texas
You will not qualify if you...
- Active use of systemic anti-inflammatory prescription medications including steroids unless used as prophylaxis during cancer treatment
- History of psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder
- Sleep disorders including obstructive sleep apnea, narcolepsy, periodic limb movement disorder
- Obesity hypoventilation syndrome, glaucoma, congenital or acquired blindness, significant cataracts or retinal disease
- Night shift workers
- Hospital Anxiety and Depression Scale score of 21 or higher or use of antidepressants unless stable for at least 1 month
- Use of hypnosedative drugs or stimulants unless stable for at least 1 month
- Use of monoamine oxidase inhibitors, tricyclic antidepressants, or anticoagulants
- Bright sunlight exposure for 30 minutes or more daily in past month, prior exposure to Bright Light Therapy, or prior use of melatonin, methylphenidate, or CBT
- Other medical reasons increasing patient risk as determined by principal investigator
- For MRI participants: presence of metallic objects in the body, claustrophobia
- Pregnancy as documented in medical record
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sriram Yennu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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