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RECRUITING
NCT07633236
PHASE3

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

Sponsor: Blokhin's Russian Cancer Research Center

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-03-28

Completion Date

2027-05-31

Last Updated

2026-06-08

Healthy Volunteers

No

Interventions

DRUG

OLANZapine 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