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

StatusActive, Not Recruiting
PhasePhase 2/3
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Final enrollment: 169 participants (planned 188)
    • Eligibility criteria expanded, about 19 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv10
  3. Eligibility criteria expanded, about 35 wordsv9
  4. Re-verified, no change to tracked fieldsv8
  5. Eligibility criteria expanded, about 63 words
    • Study description expanded, about 179 words
    v7
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  1. Eligibility criteria expanded, about 44 wordsv6
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2022 to Nov 21, 2022
    • Site details revised
    v4
  4. Primary endpoint revised
    • Interventions: Bright Light Therapy (Behavioral), Cognitive Behavior Therapy (Behavioral), Melatonin (Drug), Methylphenidate (Drug) to Melatonin (Drug), Melatonin (Drug), Methylphenidate (Drug), Placebo for Melatonin (Other)
    v3
  5. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
M.D. Anderson Cancer Center
1,231 trials monitored
See 85 trials at risk
Anxiety
3,284 trials monitored
See 154 trials at risk
Depression
3,069 trials monitored
See 170 trials at risk
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.
Trial Details
NCT Number NCT05474846
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Sleep, Fatigue, Anxiety, Cancer, Depression
Related terms Anxiety Disorders, Depression, Fatigue, Neoplasms
Enrollment 169 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov