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ACTIVE NOT RECRUITING
NCT00488072
PHASE2

Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

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).

Official title: Preliminary Study to Explore the Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2007-01-08

Completion Date

2027-12-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

Mirtazapine

15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.

DRUG

Placebo

One placebo tablet by mouth daily.

Locations (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, United States