Effects of Mirtazapine on Appetite in Advanced Cancer Patients
Status:
Active, not recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
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).