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

NCT07633236 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-06-08

No results posted yet for this study

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
  • Cachexia-Anorexia Syndrome
  • Oncology

Interventions

DRUG

OLANZapine 2.5 MG

olanzapine 2.5 mg every day within preoperative chemotherapy before surgery

Sponsors & Collaborators

  • Blokhin's Russian Cancer Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-28
Primary Completion
2026-12-28
Completion
2027-05-31

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633236 on ClinicalTrials.gov