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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07633236

Enrollment

100

Registered

2026-06-08

Start date

2025-03-28

Completion date

2027-05-31

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cachexia-Anorexia Syndrome, Oncology, Oncology Patients Receiving Chemotherapy

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

Interventions

DRUGOLANZapine 2.5 MG

olanzapine 2.5 mg every day within preoperative chemotherapy before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Proportion of patients with ≤5% weight loss	from enrollment to the end of preoperative chemotherapy

Countries

Russia

Contacts

CONTACTOlga Palchinskaia

kfoli@mail.ru+7 916 991 06 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026