Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant/Preoperative Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OLANZapine 2.5 MG.
- Who it may be relevant to
- Registry conditions: Oncology Patients Receiving Chemotherapy, Cachexia-Anorexia Syndrome, Oncology. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients With Localized and Locally Advanced Tumors Receiving Neoadjuvant/Preoperative Chemotherapy
Overview
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
- Drug OLANZapine 2.5 MG
olanzapine 2.5 mg every day within preoperative chemotherapy before surgery
Primary outcome measures
- Proportion of patients with ≤5% weight loss [Time frame: from enrollment to the end of preoperative chemotherapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Russia · 1 center
- Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Onco — Moscow
Identifiers
NCT: NCT07633236 · 14