Effects of Mirtazapine on Appetite in Advanced Cancer Patients

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv34
  2. Primary completion date: Dec 31, 2025 to Dec 31, 2027v33
  3. Primary completion date: Dec 31, 2027 to Dec 31, 2025v32
  4. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2027v31
  5. 2 versions Re-verified since May 9, 2025, no change to tracked fieldsv29-v30
Show 27 earlier versionsHide 27 earlier versions
  1. Start date: Sep 20, 2006 to Jan 8, 2007v28
  2. Re-verified, no change to tracked fieldsv27
  3. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2025v26
  4. Trial status: Suspended to Active, Not Recruitingv25
  5. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v24
  6. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: closed to accrual
    • Primary completion date: Dec 31, 2021 to Dec 31, 2022
    • Start date: Jan 2007 to Sep 20, 2006
    v23
  7. Re-verified, no change to tracked fieldsv22
  8. Primary completion date: Jan 2020 to Dec 31, 2021
    • Study completion date: Jan 2021 to Dec 31, 2022
    v21
  9. Study completion date: Jan 2020 to Jan 2021v20
  10. Re-verified, no change to tracked fieldsv19
  11. Primary and study completion dates: Jan 2019 to Jan 2020v18
  12. Phase: Not applicable to Phase 2
    • Primary completion date: May 2017 to Jan 2019
    • Study completion date: Jan 2019
    v17
  13. Re-verified, no change to tracked fieldsv16
  14. Primary completion date: May 2015 to May 2017
    • Study site revised
    v15
  15. Primary completion date: Jan 2015 to May 2015v14
  16. Primary completion date: Jan 2014 to Jan 2015v13
  17. Primary completion date: Jan 2013 to Jan 2014v12
  18. Re-verified, no change to tracked fieldsv11
  19. Primary completion date: Jan 2012 to Jan 2013v10
  20. Primary completion date: Jan 2011 to Jan 2012v9
  21. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  22. Study site revisedv7
  23. Primary completion date: Dec 2010 to Jan 2011v6
  24. Primary completion date: Dec 2009 to Dec 2010
    • Primary endpoint revised
    • Secondary endpoint revised
    • Eligibility criteria shortened, about 2 words
    v5
  25. Primary completion date: Sep 2008 to Dec 2009
    • Secondary endpoints: details revised at 1 of 1 entry
    v4
  26. Primary endpoint revisedv3 Show 4 more changesShow less
    • Primary completion date: Sep 2008
    • Study completion date: Sep 2008 to not stated
    • Secondary endpoints: 2 to 1
    • Study description shortened, about 15 words
  27. Study completion date: Sep 2008
    • Study arms: 0 to 2
    • Study title shortened, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Primary objective: This is a preliminary study to determine if Mirtazapine in comparison to placebo will improve appetite in advanced cancer patients with anorexia and weight loss. An improvement of appetite is defined as a decrease of 2 in the appetite score from baseline on the Edmonton Symptom Assessment Scale (ESAS) at day 15 (+/-3 days). Secondary objective-A: To determine if Mirtazapine in comparison to placebo will improve insomnia ( as measured by Pittsburgh Sleep Quality Index) on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) Secondary objective - B: To determine if Mirtazapine in comparison to placebo will improve other common symptoms such as pain, nausea and fatigue( as measured by ESAS), depression and anxiety ( as measured by Hospital Anxiety and Depression scale), and quality of life ( as measured by Functional Assessment of Anorexia/Cachexia Therapy ) in advanced cancer patients with anorexia/cachexia, on days 15 (+/-3 days), and 29 (+/-3 days) Other Objectives: To provide exploratory data on the effects of Mirtazapine on weight gain, and preservation/gain lean muscle mass ( anthropometric measurements and Bioelectric Impedance), on days 15 (+/-3 days), and 29 (+/-3 days). To provide exploratory data on the effects of a Mirtazapine dose increase to 30 mg on decreased side effects of drug and increased appetite on day 29 (+/-3 days).
Trial Details
NCT Number NCT00488072
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Advanced Cancer, Anorexia, Weight Loss, Insomnia
Related terms Anorexia, Sleep Initiation and Maintenance Disorders, Weight Loss
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov