98 Participants Needed

Mirtazapine for Cancer-related Appetite Loss

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
Must be taking: Antidepressants
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Research shows that mirtazapine may help improve appetite in some cancer patients, with one study finding that 56% of participants experienced improved appetite after eight weeks. However, it was less effective than another drug, megestrol, in increasing appetite and weight.12345

Is mirtazapine generally safe for humans?

Mirtazapine is generally considered safe for humans, with few adverse events reported. However, stopping it suddenly can cause symptoms like anxiousness, nausea, and tremors, so it's important to taper off the medication gradually.14678

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

SD

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

I can keep taking my current medications and therapies with my doctor's approval.
Ability to provide informed consent and comply with study procedures
Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment.
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Exclusion Criteria

Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting
I am not using benzodiazepines regularly.
I am currently on tube feeding or parenteral nutrition.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive mirtazapine or placebo for 15 days, followed by dose adjustments for mirtazapine group

4 weeks
3 visits (in-person), 4 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

Treatment Details

Interventions

  • Mirtazapine
  • Placebo
Trial OverviewThe 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.
Participant Groups
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.

Mirtazapine is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Remeron for:
  • Major depressive disorder
🇪🇺
Approved in European Union as Avanza for:
  • Major depressive episodes

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Findings from Research

Mirtazapine and olanzapine are effective alternatives for managing chemotherapy-related nausea, showing similar binding affinity to 5-HT3 receptors as standard treatments like ondansetron, but with longer half-lives and lower costs.
These medications not only reduce nausea but also improve sleep quality and appetite in patients with advanced cancer, suggesting they should be considered first-line treatments alongside traditional anti-nausea medications.
Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects.Kast, RE., Foley, KF.[2018]
Vandetinib is a promising new oral medication for advanced non-small cell lung cancer, shown to be safe for once-daily dosing up to 300 mg in Phase I studies.
Phase II clinical trials indicate that vandetinib may enhance treatment effectiveness when used alongside chemotherapy, with further research ongoing to explore its full potential.
Dual targeting of the vascular endothelial growth factor receptor and epidermal growth factor receptor pathways with vandetinib (ZD6474) in patients with advanced or metastatic non-small cell lung cancer.Natale, RB.[2022]
Vandetanib significantly increases the plasma levels of metformin and digoxin when taken together, suggesting that patients may need closer monitoring and possible dose adjustments for these medications.
No significant drug-drug interactions were observed between vandetanib and midazolam or the proton pump inhibitor omeprazole and the H2-receptor antagonist ranitidine, indicating that these combinations are likely safe.
Pharmacokinetic evaluations of the co-administrations of vandetanib and metformin, digoxin, midazolam, omeprazole or ranitidine.Johansson, S., Read, J., Oliver, S., et al.[2022]

References

[Efficacy of mirtazapine for appetite loss and nausea of the cancer patient--from clinical experience in Memorial Sloan-Kettering Cancer Center]. [2018]
Phase II trial of mirtazapine for cancer-related cachexia and anorexia. [2018]
Mirtazapine versus Megestrol in the Treatment of Anorexia-Cachexia Syndrome in Patients with Advanced Cancer: A Randomized, Double-Blind, Controlled Phase II Clinical Trial. [2023]
Mirtazapine in Cancer-Associated Anorexia and Cachexia: A Double-Blind Placebo-Controlled Randomized Trial. [2022]
Intervention of mirtazapine on gemcitabine-induced mild cachexia in nude mice with pancreatic carcinoma xenografts. [2022]
Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects. [2018]
The Hunger for Mirtazapine: A Discontinuation Syndrome. [2021]
The effect of mirtazapine on gastric accommodation, gastric sensitivity to distention, and nutrient tolerance in healthy subjects. [2018]
Dual targeting of the vascular endothelial growth factor receptor and epidermal growth factor receptor pathways with vandetinib (ZD6474) in patients with advanced or metastatic non-small cell lung cancer. [2022]
Pharmacokinetic evaluations of the co-administrations of vandetanib and metformin, digoxin, midazolam, omeprazole or ranitidine. [2022]
Vandetanib: An overview of its clinical development in NSCLC and other tumors. [2022]
ZD6474--clinical experience to date. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Discovery and Evaluation of Clinical Candidate AZD3759, a Potent, Oral Active, Central Nervous System-Penetrant, Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor. [2018]