Olanzapine to prevent and treat appetite loss in cancer patients getting preoperative chemo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 trial, adults with localized or locally advanced ovarian or gastric cancer receiving neoadjuvant chemotherapy will be randomized to receive a prolonged low-dose olanzapine (2.5 mg/day) plus standard care or standard care alone. The study will assess weight changes, appetite, nausea, treatment adherence, nutritional status, and quality of life, with evaluations before chemotherapy and after chemotherapy before surgery, plus follow-up for surgical complications. Safety and adverse events will be monitored at every visit. The aim is to determine if olanzapine can help maintain chemotherapy dose intensity and improve outcomes related to cachexia and overall wellbeing.

Why it matters

Who can join: the full rules

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 enrollment
* Current use of antipsychotics/antidepressants
* Systemic corticosteroid use (\>7 days within the last 4 weeks)
* History of psychiatric disorders

Where it's running

• Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
  Moscow, Russia Recruiting

Study contacts

• Study coordinator: Olga Palchinskaia
• Email: kfoli@mail.ru
• Phone: +7 916 991 06 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.