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Clinical Trials in Mexico / NCT04939090
Active, not recruiting Phase 3

Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients

NCT04939090 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2022-01-03
Last updated
2026-07-30

Condition(s) studied

Advanced Malignant Solid NeoplasmAnorexiaHematopoietic and Lymphoid Cell Neoplasm

Investigational drug(s) / intervention(s)

Olanzapine →Megestrol Acetate →Questionnaire Administration

Olanzapine: Given PO

Megestrol Acetate: Given PO

Questionnaire Administration: Ancillary studies

Study summary

This phase III trial compares the effects of olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer that has spread to other places in the body (advanced). Olanzapine may stimulate and increase appetite. This study aims to find out if olanzapine is better than the usual approach (megestrol acetate) for stimulating appetite and preventing weight loss.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) * Diagnosis of advanced cancer * Patient-reported 2-month weight loss of at least 5 pounds (2.3 kilograms) and/or physician-estimated caloric intake of less than 20 calories/kilogram of body weight per day * The patient must perceive loss of appetite and/or weight as a problem; and have an appetite score of 4 or worse on the "Please rate your appetite…." question that requires a patient response on a 0-10 numeric rating scale * Not receiving ongoing tube feedings or parenteral nutrition at the time of registration * Not currently using systemic adrenal steroids (with the exception of short-term dexamethasone within 3 days of chemotherapy for control of chemotherapy side effects) * No use of androgens, progesterone analogs, or other appetite stimulants within the past month * Patient should not have poorly controlled hypertension or congestive heart failure at registration * Patient should not have an obstruction of the alimentary canal, malabsorption, or intractable vomiting (defined as vomiting more than 3 times per day over the preceding week) * Not currently using olanzapine for another medical condition or had previously used olanzapine for chronic nausea or for any pre-existing psychotic disorder * Patient should not have had a previous blood clot at any time in the past * No history of poorly controlled diabetes * No symptomatic leptomeningeal disease or known brain metastases as these patients may have difficulty taking oral medications * No history of hypersensitivity to olanzapine or megestrol acetate * No COVID-19 infection in the past that, in the opinion of the treating physician, had left patients with compromised taste, which has not resolved at the time of registration * Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 14 days prior to registration is required * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Estimated life expectancy of 3 months or longer * Serum creatinine =\< 2.0 mg/dL * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) * Fasting glucose \< 140 mg/dL * Granulocytes \> 1000/hpf * No treatment with another antipsychotic agent, such as risperidone, quetiapine, clozapine, butyrophenone within 30 days of enrollment * In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English or Spanish. Sites seeking to enroll Spanish-speaking patients should have access to Spanish speaking staff on site or through the use of a translation service to be able to conduct the informed consent discussion in Spanish, and to conduct the weekly phone calls Exclusion Criteria: * Psychiatric illness which would prevent the patient from giving informed consent * Medical condition such as uncontrolled infection (including human immunodeficiency virus \[HIV\]), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient * Patients who cannot swallow oral formulations of the agents * Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study * No presence of a hormone-sensitive tumor, such as breast, endometrial, or prostate cancer (this exclusion criterion is intended to circumvent any confounding antineoplastic effects of megestrol acetate)

Primary outcome measure(s)

Trial sites (293)

FacilityCityRegionStatus
Arizona Center for Cancer Care - Gilbert Gilbert Arizona
CTCA at Western Regional Medical Center Goodyear Arizona
Arizona Center for Cancer Care-Peoria Peoria Arizona
Arizona Center for Cancer Care - Phoenix Phoenix Arizona
Arizona Center for Cancer Care - Osborn Scottsdale Arizona
Arizona Center for Cancer Care - Scottsdale Scottsdale Arizona
Arizona Center for Cancer Care-Surprise Surprise Arizona
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
Epic Care-Dublin Dublin California
Epic Care Partners in Cancer Care Emeryville California
Washington Hospital Fremont California
Contra Costa Regional Medical Center Martinez California
Bay Area Tumor Institute Oakland California
Zuckerberg San Francisco General Hospital San Francisco California
Dominican Santa Cruz Hospital Santa Cruz California
Epic Care Cyberknife Center Walnut Creek California
Rocky Mountain Cancer Centers-Aurora Aurora Colorado
Rocky Mountain Cancer Centers-Boulder Boulder Colorado
Rocky Mountain Cancer Centers - Centennial Centennial Colorado
Rocky Mountain Cancer Centers-Midtown Denver Colorado
Rocky Mountain Cancer Centers-Rose Denver Colorado
Mountain Blue Cancer Care Center - Swedish Englewood Colorado
Rocky Mountain Cancer Centers - Swedish Englewood Colorado
Grand Valley Oncology Grand Junction Colorado
Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
Rocky Mountain Cancer Centers-Thornton Thornton Colorado
Beebe South Coastal Health Campus Millville Delaware
Delaware Clinical and Laboratory Physicians PA Newark Delaware
Helen F Graham Cancer Center Newark Delaware
Medical Oncology Hematology Consultants PA Newark Delaware
Beebe Health Campus Rehoboth Beach Delaware
Christiana Care Health System-Wilmington Hospital Wilmington Delaware
Kaiser Permanente-Capitol Hill Medical Center Washington D.C. District of Columbia
Morton Plant Hospital Clearwater Florida
Halifax Health Medical Center-Centers for Oncology Daytona Beach Florida
Regional Cancer Center-Lee Memorial Health System Fort Myers Florida
Halifax Health Center for Oncology - Ormond Beach Ormond Beach Florida
South Florida Baptist Hospital Plant City Florida
Halifax Health Center for Oncology - Port Orange Port Orange Florida

+ 253 more sites — see the full list on the official registry below.

More Alliance for Clinical Trials in Oncology trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04939090 on ClinicalTrials.gov ↗ ← All trials in Mexico