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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00488072 |
Purpose
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).
| 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 |
| Estimated Enrollment: | 98 |
| Study Start Date: | January 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Mirtazapine: Experimental |
Drug: Mirtazapine
15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.
|
| Placebo: Placebo Comparator |
Drug: Placebo
One placebo tablet by mouth daily.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shalini Dalal, MD | 713-792-6085 |
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Shalini Dalal, MD | |
| Principal Investigator: | Shalini Dalal, MD | U.T.M.D. Anderson Cancer Center |
More Information
| 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: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00488072 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Advanced Cancer Anorexia Weight Loss Insomnia |
Appetite Mirtazapine Placebo |
|
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 |