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

NCT07633236 | Recruiting Phase 3

• 1 other identifier: 14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oncology Patients Receiving Chemotherapy; Oncology; Cachexia-Anorexia Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with ≤5% weight loss

  from enrollment to the end of preoperative chemotherapy

Study Arms (2)

treatment

EXPERIMENTAL

Drug: OLANZapine 2.5 MG

control

NO INTERVENTION

Interventions

OLANZapine 2.5 MG DRUG

olanzapine 2.5 mg every day within preoperative chemotherapy before surgery

treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Olanzapine

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Olga Palchinskaia

CONTACT

+7 916 991 06 23; kfoli@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 14/05/2026 - indefinitely

Locations

RU (1)