Olanzapine Versus Megestrol Acetate for the Treatment of Loss of Appetite Among Advanced Cancer Patients
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ClinicalTrials.gov Identifier: NCT04939090 |
Recruitment Status :
Recruiting
First Posted : June 25, 2021
Last Update Posted : January 13, 2022
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Condition or disease | Intervention/treatment | Phase |
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Advanced Malignant Solid Neoplasm Anorexia Hematopoietic and Lymphoid Cell Neoplasm | Drug: Olanzapine Drug: Megestrol Acetate Other: Questionnaire Administration | Phase 3 |
The primary and secondary objectives of the study:
PRIMARY OBJECTIVE:
I. To determine whether olanzapine leads to greater appetite improvement from baseline in cancer patients suffering from anorexia compared to megestrol acetate using the 0-10 numerical rating scale (NRS).
SECONDARY OBJECTIVES:
I. To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate.
II. To compare change in cachexia/anorexia symptoms with olanzapine compared to megestrol acetate using the Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS) instrument.
OUTLINE: Patient are randomized to 1 of 2 arms.
ARM I: Patients receive olanzapine orally (PO) once daily (QD) for up to 4 weeks in the absence of consent withdrawal or unacceptable toxicity.
ARM II: Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of consent withdrawal or unacceptable toxicity.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Randomized Phase III Trial of Olanzapine Versus Megestrol Acetate for Cancer-Associated Anorexia |
Actual Study Start Date : | October 15, 2021 |
Estimated Primary Completion Date : | April 1, 2023 |
Estimated Study Completion Date : | December 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I (olanzapine)
Patients receive olanzapine PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: Olanzapine
Given PO Other: Questionnaire Administration Ancillary studies |
Active Comparator: Arm II (megestrol acetate)
Patients receive megestrol acetate PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: Megestrol Acetate
Given PO Other: Questionnaire Administration Ancillary studies |
- Change in appetite [ Time Frame: Baseline up to 4 weeks ]Will be compared between the two study groups (olanzapine versus megestrol acetate) using a 0-10 numerical rating scale. Will be summarized by mean (standard deviation [SD]) and median (range) by treatment arm. The difference in appetite change from baseline to 4 weeks of treatment between arms will be estimated along with a 95% confidence interval and will be compared using a t-test or Wilcoxon rank-sum test as appropriate.
- Proportion of patients who report a 5% or greater weight gain [ Time Frame: Baseline up to 4 weeks ]The proportion of patients with a 5% or greater weight gain from baseline will be calculated for each arm. The difference in proportion of patients with 5% or greater weight gain between the arms will be estimated along with a 95% confidence interval using a normal approximation of the binomial distribution and will be compared using a Chi-squared test.
- Change in well-being status and cachexia/anorexia symptoms [ Time Frame: Baseline up to 4 weeks ]Responses to the Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS) questionnaire will be scored according to the established algorithm. The total score of the FAACT-A/CS will be summarized weekly and the change from baseline to 4 weeks will be compared between the treatment arms using the same methods described for the primary endpoint.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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 > 1410 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939090
Contact: Aminah Jatoi, MD | 507-266-9160 | Jatoi.aminah@mayo.edu |

Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT04939090 |
Other Study ID Numbers: |
A222004 NCI-2021-03303 ( Registry Identifier: NCI Clinical Trial Reporting Program ) UG1CA189823 ( U.S. NIH Grant/Contract ) |
First Posted: | June 25, 2021 Key Record Dates |
Last Update Posted: | January 13, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms Anorexia Signs and Symptoms, Digestive Megestrol Megestrol Acetate Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Contraceptives, Oral, Hormonal Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Hormonal Contraceptives, Oral, Synthetic Antineoplastic Agents, Hormonal Antineoplastic Agents |