Home › Trials › NCT04939090

Comparing olanzapine and megestrol acetate for treating appetite loss in advanced cancer patients

A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia

Phase 3 Interventional Alliance for Clinical Trials in Oncology · NCT04939090

This study tests whether olanzapine can help improve appetite better than megestrol acetate in people with advanced cancer who are struggling with appetite loss.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment360 (estimated)
Ages18 Years and up
SexAll
SponsorAlliance for Clinical Trials in Oncology Academic / other
Drugs / interventionschemotherapy
Locations272 sites (Gilbert, Arizona and 271 other locations)
Trial IDNCT04939090 on ClinicalTrials.gov

What this trial studies

This phase III trial investigates the effectiveness of olanzapine compared to megestrol acetate in improving appetite among patients with advanced cancer experiencing anorexia. Participants will be randomly assigned to receive either olanzapine or megestrol acetate for up to four weeks. The primary objective is to assess appetite improvement using a numerical rating scale, while secondary objectives include evaluating weight gain and changes in anorexia/cachexia symptoms. The study aims to determine if olanzapine is a superior option for stimulating appetite and preventing weight loss in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with advanced cancer who have experienced significant weight loss and report a loss of appetite.

Not a fit: Patients who are currently receiving tube feedings or parenteral nutrition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for appetite loss in advanced cancer patients, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown varying degrees of success with appetite stimulants in cancer patients, but this specific comparison of olanzapine and megestrol acetate is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Gilbert, Arizona and 271 other locations

+222 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Malignant Solid NeoplasmAnorexiaHematopoietic and Lymphoid Cell Neoplasm
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.