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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBlokhin's Russian Cancer Research Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • OLANZapine 2.5 MG

    Drug

    olanzapine 2.5 mg every day within preoperative chemotherapy before surgery

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: treatmentExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of patients with ≤5% weight loss

Time frame
from enrollment to the end of preoperative chemotherapy

Secondary outcomes

Other outcomes

Sponsors and contacts

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