Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant/Preoperative Chemotherapy
Recruiting
Phase 3
Interventional Study
Oncology Patients Receiving Chemotherapy
Cachexia-Anorexia Syndrome
Oncology
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 100 (estimated)
- Sponsor
- Blokhin's Russian Cancer Research Center · Other
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About This Trial
The goal of this clinical trial is to learn if olanzapine works to prevent and treat anorexia-cachexia syndrome and appetite loss in cancer patients. The main questions it aims to answer are:
Is prolonged low-dose olanzapine effective and save in:
* Preventing/treating weight loss due to anorexia.
* Controlling nausea/vomiting.
* Maintaining anticancer therapy dose intensity?
Does prolonged low…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* ECOG status 0-2
* Localized/locally advanced ovarian or gastric cancer requiring neoadjuvant/preoperative chemotherapy followed by surgery
* Ability to consume food/medications orally
Exclusion Criteria:
* Olanzapine use (\>4 days) for other indications at en…
Contacts