Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mirtazapine, Olanzapine.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa with Significantly Low Body Weight. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
Overview
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Detailed description
Olanzapine and Mirtazapine have been used in the past few years to attempt to prevent weight and appetite loss in cancer patients. Both have mixed study results and none of the previous studies are of high enough quality to make clinical recommendations. With limited options available, palliative and oncology providers turn to these medications with little evidence. There are no formal studies comparing the two to determine if one is superior to the other, so choices are often made based purely on provider preference. We aim to conduct a study to determine if one of the drugs outperforms the other to guide our standard practice at Englewood Health. This study is being conducted to determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Interventions
- Drug Mirtazapine
Patients will be prescribed a dosage of 15 mg per day. Dose will not be escalated. - Drug Olanzapine
the participant will be prescribed a dosage of 2.5mg per day if \> 65 yrs. and 5 mg/per day if \<65 yrs. per day. Per physician discretion, participants are allowed a dose escalation of a maximum of 10mg.
Primary outcome measures
- Weight [Time frame: 6 months]
Secondary outcome measures (1)
- Quality of Life of patient [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- • 18 years of age or older
- Able to provide informed consent
- Pathologically and/or clinically confirmed diagnosis of advanced cancer
- At any point of treatment with standard chemotherapy\*
o Scheduled to start, have discontinued or completed, or currently receiving
- Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation
o Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period).
- Life expectancy of at least 4 months
- Able to communicate well and comply with study requirements, including by phone and written logs
- Patients on Dexamethasone will be allowed
Exclusion criteria
- • Abnormal liver function defined as > twice upper limit of normal
- Elevated QTc
o 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
- Taking Marinol within 2 week of enrollment onto study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Englewood Health — Englewood
Identifiers
NCT: NCT05170919 · E-21-862