RecruitingPhase 3NCT07633236

Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant/Preoperative Chemotherapy

Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients With Localized and Locally Advanced Tumors Receiving Neoadjuvant/Preoperative Chemotherapy


Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

100 participants

Start Date

Mar 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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-dose olanzapine improve quality of life in patients receiving neoadjuvant/preoperative chemotherapy? Participants will: Take prolonged low-dose olanzapine (2.5 mg/day) in treatment group or usual diet only in control group until surgical treatment Physical examination, anthropometric assessment, blood tests, quality of life, appetite and nutritional status assessment, abdominal CT, handgrip dynamometry before chemotherapy and after preoperative chemotherapy before surgery Physical examination, adverse events every visit Surgical complications within 30 days after surgery


Eligibility

Inclusion Criteria4

  • 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 Criteria4

  • 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

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Interventions

DRUGOLANZapine 2.5 MG

olanzapine 2.5 mg every day within preoperative chemotherapy before surgery


Locations(1)

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

Moscow, Russia

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NCT07633236


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