Mirtazapine for Cancer-related Appetite Loss
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
You can continue taking your current medications, including complementary therapies or cancer treatments, as long as you have been on a stable dose for at least 2 weeks and have your doctor's permission.
What data supports the effectiveness of the drug mirtazapine for cancer-related appetite loss?
Is mirtazapine generally safe for humans?
How does the drug Mirtazapine differ from other treatments for cancer-related appetite loss?
Mirtazapine is unique because it is primarily an antidepressant that also has appetite-stimulating effects, which can be beneficial for cancer patients experiencing appetite loss. Unlike other treatments that may focus directly on cancer symptoms, Mirtazapine's dual action on mood and appetite makes it a novel option for addressing both psychological and physical aspects of cancer-related appetite loss.910111213
Research Team
Shalini Dalal, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Adult cancer patients with anorexia and weight loss can join this trial. They must be able to consent, follow the study plan, and attend clinic visits. Pregnant women or those on certain medications like corticosteroids are excluded, as well as patients with dementia or severe depression/anxiety.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mirtazapine or placebo for 15 days, followed by dose adjustments for mirtazapine group
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Mirtazapine
- Placebo
Mirtazapine is already approved in United States, European Union for the following indications:
- Major depressive disorder
- Major depressive episodes
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor