NCT07633236 Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant/Preoperative Chemotherapy
| NCT ID | NCT07633236 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Blokhin's Russian Cancer Research Center |
| Condition | Oncology Patients Receiving Chemotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-28 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2025-03-28 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07633236 clinical trial?
This trial is open to participants of all sexes, studying Oncology Patients Receiving Chemotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07633236 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT07633236 currently recruiting?
Yes, NCT07633236 is actively recruiting participants. Contact the research team at kfoli@mail.ru for enrollment information.
Where is the NCT07633236 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07633236 clinical trial?
NCT07633236 is sponsored by Blokhin's Russian Cancer Research Center. The trial plans to enroll 100 participants.