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NCT Number: NCT07633236

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

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

Recruiting

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Key information

Conditions

Oncology Patients Receiving Chemotherapy Cachexia-Anorexia Syndrome Neoplasms Oncology

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Moscow, Russia

Location status: Recruiting

Location contact

Olga Palchinskaia

CONTACT

[email protected]

+7 916 991 06 23

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OLANZapine 2.5 MG

Drug

olanzapine 2.5 mg every day within preoperative chemotherapy before surgery

Primary outcomes

  1. Proportion of patients with ≤5% weight loss

    Time frame: from enrollment to the end of preoperative chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Olga Palchinskaia

CONTACT

[email protected]

+7 916 991 06 23

Sponsors and collaborators

Lead sponsor

Blokhin's Russian Cancer Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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