Olanzapine and Mirtazapine for Weight Loss in Advanced Stage Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Englewood Hospital and Medical Center

Must not be taking: Marinol

Disqualifiers: Abnormal liver function, Elevated QTc, TPN/enteral feeds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two medications, olanzapine and mirtazapine, to see which one helps cancer patients keep their weight and appetite. Cancer patients often lose weight and appetite, and these drugs might help by making them feel better emotionally and physically. Olanzapine and mirtazapine have been shown to improve appetite and reduce nausea in cancer patients, which can help with weight maintenance.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take Marinol within two weeks of joining the study. Patients on Dexamethasone are allowed to participate.

Is the combination of olanzapine and mirtazapine safe for humans?

Olanzapine and mirtazapine are generally considered safe for humans, with low risk for drug interactions and minimal side effects compared to other medications. They are used to manage symptoms like nausea and appetite loss in cancer patients, and studies suggest they are well-tolerated. ^{1 2 3 4 5}

How do the drugs olanzapine and mirtazapine help with weight loss in advanced cancer patients?

Olanzapine and mirtazapine are unique because they not only help with nausea and appetite increase in advanced cancer patients but also have fewer side effects and drug interactions compared to other treatments. They are also easier to use with once- or twice-daily dosing and are more cost-effective than standard nausea medications. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced cancer who have lost more than 5% of their weight unintentionally over the last 3-6 months, despite nutritional support. They must be able to consent, communicate effectively, and have a life expectancy of at least 4 months. Those on dexamethasone or undergoing chemotherapy can join. People using Marinol recently, with abnormal heart rhythms or liver function, or primarily fed intravenously cannot participate.

Inclusion Criteria

You have lost more than 5% of your body weight over the last 3-6 months without trying to lose weight. This is not due to just not eating, and has not improved with standard nutrition advice and supplements for at least 2 weeks.

Able to provide informed consent

Pathologically and/or clinically confirmed diagnosis of advanced cancer

Exclusion Criteria

You have taken Marinol within two weeks before joining the study.

Elevated QTc (EKG performed within 1 year of enrollment will be accepted)

Total parental nutrition (TPN) or enteral feeds (PEG/PEJ) for >70% of their primary source of daily calorie intake

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Olanzapine or Mirtazapine to assess their effectiveness in preventing weight and appetite loss

6 months

Monthly visits for weight measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mirtazapine
• Olanzapine

Trial Overview The study aims to compare the effectiveness of two medications, Olanzapine and Mirtazapine, in preventing further weight loss and appetite loss in patients with advanced stage cancer. It will assess which drug better helps manage these symptoms associated with cancer.

How Is the Trial Designed?

Group I: Olanzapine Experimental Treatment 1 Intervention

Group II: Mirtazapine Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Englewood Hospital and Medical Center

Lead Sponsor

Trials

21

Recruited

770+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects. Kast, RE., Foley, KF.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Cancer chemotherapy and cachexia: mirtazapine and olanzapine are 5-HT3 antagonists with good antinausea effects. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Appetite Stimulant and Anti-Emetic Effect of Mirtazapine Transdermal Ointment in Cats Affected by Lymphoma Following Chemotherapy Administration: A Multi-Centre Retrospective Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of mirtazapine for cancer-related cachexia and anorexia. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Mirtazapine in Cancer-Associated Anorexia and Cachexia: A Double-Blind Placebo-Controlled Randomized Trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Management of symptoms associated with advanced cancer: olanzapine and mirtazapine. A World Health Organization project. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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]