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Effects of Mirtazapine on Appetite in Advanced Cancer Patients
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2008
First Received: June 18, 2007   Last Updated: December 22, 2008   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00488072
  Purpose

Primary Objective:

1. 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 Objectives:

  1. 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).
  2. 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).

Condition Intervention
Advanced Cancer
Anorexia
Weight Loss
Insomnia
Drug: Mirtazapine
Drug: Placebo

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Preliminary Study to Explore the Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find out if Remeron (mirtazapine) can help to improve appetite in patients with advanced cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To learn if mirtazapine can help to improve quality of life for these patients by decreasing common symptoms of advanced cancer (such as insomnia [difficulty sleeping], nausea, pain, and mood change). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 98
Study Start Date: January 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Mirtazapine
Drug: Mirtazapine
Randomization Portion = 15 mg PO daily x 15 days; Open Label Portion = 15 mg PO daily beginning day 15 and continuing until day 22. On day 22, Mirtazapine will be increased to 30 mg PO daily and this dose will continue until day 29.
2: Placebo Comparator
Placebo
Drug: Placebo
Randomization Portion = One tablet PO daily x 15 days; Open Label Portion = 15 mg PO daily Mirtazapine beginning day 15 and continuing until day 22. On day 22, Mirtazapine will be increased to 30 mg PO daily and this dose will continue until day 29.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced cancer patients seen in outpatient clinics at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS.
  • Patients > 18 years of age
  • Karnofsky Performance score of > 40 at time of inclusion into study
  • Ability to provide informed consent and comply with study procedures
  • Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days).
  • Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment.
  • For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist
  • Drowsiness of </= 4/10 on ESAS at baseline due to known potential sedating effects of Mirtazapine
  • Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study (with the permission of their Attending MD) if they have been on stable dose for at least 2 weeks.

Exclusion Criteria:

  • Patients who have known dementia or delirium at time of enrollment as determined by a physician.
  • Known hypersensitivity to any ingredient of Mirtazapine
  • Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting
  • Ongoing use of tube feeding or parenteral nutrition
  • Use of any antidepressant medication for longer than one week in the past month prior to study enrollment.
  • Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment.
  • Pregnancy or lactation or unwillingness to use contraceptives
  • A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation.
  • Patients on chronic use of benzodiazepines are excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488072

Contacts
Contact: Shalini Dalal, MD 713-792-6085

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Shalini Dalal, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Shalini Dalal, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Shalini Dalal, MD/Assistant Professor )
Study ID Numbers: 2005-0916
Study First Received: June 18, 2007
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00488072     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Anorexia
Weight Loss
Insomnia
Appetite
Mirtazapine
Placebo

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic Agents
Signs and Symptoms, Digestive
Psychotropic Drugs
Adrenergic alpha-Antagonists
Mirtazapine
Antidepressive Agents, Tricyclic
Histamine
Body Weight
Signs and Symptoms
Histamine Antagonists
Weight Loss
Anorexia
Body Weight Changes
Histamine H1 Antagonists
Histamine phosphate
Adrenergic Antagonists
Antidepressive Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Psychotropic Drugs
Histamine Agents
Adrenergic alpha-Antagonists
Mirtazapine
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Body Weight
Signs and Symptoms
Neoplasms
Histamine Antagonists
Therapeutic Uses
Weight Loss
Anorexia
Body Weight Changes
Histamine H1 Antagonists
Adrenergic Antagonists
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on July 06, 2009