Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Niharika Dixit
Headshot of Niharika Dixit
Niharika Dixit

Description

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.

Official Title

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

Details

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Keywords

Advanced Malignant Solid Neoplasm, Anorexia, Hematopoietic and Lymphoid Cell Neoplasm, Neoplasms, Megestrol, Megestrol Acetate, Olanzapine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • Zuckerberg San Francisco General Hospital accepting new patients
    San Francisco California 94110 United States
  • Epic Care Partners in Cancer Care in progress, not accepting new patients
    Emeryville California 94608 United States
  • Bay Area Tumor Institute in progress, not accepting new patients
    Oakland California 94609 United States
  • Contra Costa Regional Medical Center in progress, not accepting new patients
    Martinez California 94553-3156 United States
  • Epic Care Cyberknife Center in progress, not accepting new patients
    Walnut Creek California 94597 United States
  • Epic Care-Dublin in progress, not accepting new patients
    Dublin California 94568 United States
  • Comprehensive Cancer Centers of Nevada - Town Center accepting new patients
    Las Vegas Nevada 89144 United States

Lead Scientist at UCSF

  • Niharika Dixit
    Professor, Medicine, School of Medicine. Authored (or co-authored) 39 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT04939090
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 360 study participants
Last Updated