Clinical trial · Interventional
Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
An Efficacy Study Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer
NCT05170919CI-TRIAL-00080497enrolling by invitationPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine whether olanzapine or mirtazapine is more effective in preventing weight loss and appetite loss in cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia Nervosa with Significantly Low Body Weight | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mirtazapine | Drug | — | UNRESOLVED |
| Olanzapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Olanzapine
- interventionNames
- Drug: Olanzapine
- type
- EXPERIMENTAL
- label
- Mirtazapine
- interventionNames
- Drug: Mirtazapine
Primary outcomes (1)
- measure
- Weight
- timeFrame
- 6 months
- description
- Patients will have their weight measured every month. A ratio of 5% weight gain or weight stabilization over time will be used to determine if the medication is making an impact.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 studyReferences
Publications (0)
Data not yet available
No reference posted for this study.