Effects of Mirtazapine on Appetite in Advanced Cancer Patients (NCT00488072) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Effects of Mirtazapine on Appetite in Advanced Cancer Patients
United States98 participantsStarted 2007-01-08
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Advanced cancer patients seen in outpatient clinics or inpatient units 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
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
. 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