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
|Condition or disease||Intervention/treatment||Phase|
|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:
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).
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|
|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|
Experimental: Arm I (olanzapine)
Patients receive olanzapine PO QD for up to 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: Questionnaire Administration
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.
Drug: Megestrol Acetate
Other: Questionnaire Administration
- 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.
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.firstname.lastname@example.org|
|Study Chair:||Aminah Jatoi, MD||Mayo Clinic|