Oncology Patients Receiving ChemotherapyPhase 3NCT07633236
Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients Receiving Neoadjuvant/Preoperative Chemotherapy
A Phase 3 study testing OLANZapine 2.5 MG in people with Oncology Patients Receiving Chemotherapy and Cachexia-Anorexia Syndrome, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oncology Patients Receiving Chemotherapy, Cachexia-Anorexia Syndrome, Oncology
- What is being tested?
- OLANZapine 2.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 28 Mar 2025to 31 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
Moscow
Olga Palchinskaia, +7 916 991 06 23, kfoli@mail.ru
About this study
Official title: Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients With Localized and Locally Advanced Tumors Receiving Neoadjuvant/Preoperative Chemotherapy
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:
Read more
- 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
- Being tested
- OLANZapine 2.5 MG
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLANZapine 2.5 MGDrug
olanzapine 2.5 mg every day within preoperative chemotherapy before surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: OLANZapine 2.5 MG |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with ≤5% weight loss
Measured: from enrollment to the end of preoperative chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start28 Mar 2025
- Primary completion28 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology Patients Receiving ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633236
- Sponsor's protocol ID
- 14
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine in the Prevention and Treatment of Anorexia-Cachexia Syndrome in Patients With Localized and Locally Advanced Tumors Receiving Neoadjuvant/Preoperative Chemotherapy
- ClinicalTrials.gov ID
- NCT07633236
- Acronym / sponsor ID
- 14
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: OLANZapine 2.5 MG |
| control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLANZapine 2.5 MGolanzapine 2.5 mg every day within preoperative chemotherapy before surgery | Drug | treatment |
Primary outcome
Proportion of patients with ≤5% weight loss
Time frame: from enrollment to the end of preoperative chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: Yes. all IPD collected throughout the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OLANZapine 2.5 MG in people with Oncology Patients Receiving Chemotherapy and Cachexia-Anorexia Syndrome, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Palchinskaia (+7 916 991 06 23, kfoli@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with ≤5% weight loss (time frame: from enrollment to the end of preoperative chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.