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Antidepressant

Mirtazapine for Cancer-related Appetite Loss

Phase 2
Waitlist Available
Led By Shalini Dalal, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Karnofsky Performance score of > 40 at time of inclusion into study
Must not have
Patients on chronic use of benzodiazepines are excluded
Pregnancy or lactation or unwillingness to use contraceptives
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and on days (+/-3) 15 and 28

Summary

This trial is testing whether Mirtazapine can help improve appetite, insomnia, and other symptoms in advanced cancer patients with anorexia and weight loss.

Who is the study for?
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.
What is being tested?
The trial is testing if Mirtazapine improves appetite in advanced cancer patients compared to a placebo. It also looks at sleep quality, pain relief, mood changes, and quality of life over about a month.
What are the potential side effects?
Mirtazapine may cause drowsiness (which is why people already very sleepy can't join), increased appetite which could lead to weight gain, dry mouth, constipation or diarrhea. Some might feel dizzy or have abnormal dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer, lost more than 5% of my weight in 6 months, and feel a strong lack of appetite.
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I can care for myself but may not be able to do active work.
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I have been on a stable dose of antidepressants for at least 2 months.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not using benzodiazepines regularly.
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I am not pregnant, breastfeeding, and I am willing to use contraceptives.
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I am currently on tube feeding or parenteral nutrition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and on days (+/-3) 15 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, and on days (+/-3) 15 and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of ESAS scores in Appetite

Side effects data

From 2014 Phase 4 trial • 38 Patients • NCT01178671
44%
nausea
43%
decreased libido (men)
43%
sexual dysfunction (men)
33%
fatigue
28%
sweating
28%
constipation
28%
somnolence
28%
decreased appetite
28%
dry mouth
28%
urinary dysfunction
28%
diarrhea
28%
tremor
27%
decreased libido (women)
22%
forgetfulness
22%
lightheadedness
22%
impaired concentration
18%
sexual dysfunction (women)
17%
heartburn
17%
apathy
17%
emesis
17%
headache
11%
insomnia
11%
increased appetite
11%
incoordination
11%
blurry vision
6%
restlessness
6%
nervousness
6%
skin problems
6%
bruising
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertraline and Sugar Pill
Sertraline and Mirtazapine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MirtazapineExperimental Treatment1 Intervention
Mirtazapine 15 mg by mouth (PO) daily for 15 days; Day 22-29, increased to 30 mg PO daily.
Group II: PlaceboPlacebo Group1 Intervention
One placebo tablet by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
2012
Completed Phase 4
~409200

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,147 Total Patients Enrolled
10 Trials studying Obesity
2,518 Patients Enrolled for Obesity
Shalini Dalal, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Mirtazapine (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT00488072 — Phase 2
Obesity Research Study Groups: Placebo, Mirtazapine
Obesity Clinical Trial 2023: Mirtazapine Highlights & Side Effects. Trial Name: NCT00488072 — Phase 2
Mirtazapine (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00488072 — Phase 2
~6 spots leftby Dec 2025
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