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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05474846
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Melatonin — DRUG
    Given by PO
  • Placebo for Melatonin — OTHER
    Given by PO
  • Melatonin — DRUG
    Given by PO
  • Methylphenidate — DRUG
    Given by PO

Study Details

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.

Key Dates

Start date
Nov 21, 2022
Status verified
Nov 2025
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy (BLT+MT+MP with CBT)
    Patients receive Melatonin (called MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
  • Experimental: Placebo (CLT+ placebo MT + placebo MP with CBT)
    Patients receive placebo Melatonin (called placebo MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
  • Experimental: Bright light and Melatonin (BLT + MT+ placebo MP with CBT)
    Patients receive Bright Light Therapy (called BLT) for 30 minutes daily for 6 weeks, Melatonin (called MT) PO QD for 6 weeks, placebo Methylphenidate (called placebo MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.
  • Experimental: Methylphenidate (CLT + placebo MT + MP with CBT)
    Patients receive Control Light Therapy (called CLT) for 30 minutes daily for 6 weeks, placebo Melatonin (called placebo MT) PO QD for 6 weeks, Methylphenidate (called MP) PO BID for 6 weeks, and Cognitive Behavior Therapy (called CBT) weekly for 6 weeks.

Primary Outcome Measure

Pittsburgh Sleep Quality Index (PSQI) questionnaires [ Time Frame: Through the study completion, an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Sriram Yennu, MD
[email protected]
713-792-6085
Sriram Yennu, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
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By specialty
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By research site
MD Anderson Cancer Center· Houston, TX

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