drugset / Trial / NCT07124195

Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting

NCT07124195

Phase 3 Not yet recruiting 126 enrolled The First Affiliated Hospital of Xinxiang Medical College
RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this clinical trial is to learn if medroxyprogesterone acetate oral suspension (Meishiya®) works to prevent nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) in the whole-process management. It will also learn about the safety of medroxyprogesterone acetate oral suspension (Meishiya®). The main questions it aims to answer are: Does medroxyprogesterone acetate oral suspension (Meishiya®) effectively prevent nausea and vomiting induced by single-day MEC/HEC in the whole-process management? What medical problems do participants have when taking medroxyprogesterone acetate oral suspension (Meishiya®)? Researchers will adopt a multicenter, randomized controlled, open-label trial design and compare the effects of medroxyprogesterone acetate oral suspension (Meishiya®) in preventing chemotherapy-induced nausea and vomiting. Participants will be: Stratified based on chemotherapy regimens (HEC vs MEC), gender (male vs female), and age (\<55 years vs ≥55 years) Planned to be 126 subjects who are first-time recipients of single-day MEC/HEC for malignant solid tumors Take medroxyprogesterone acetate oral suspension (Meishiya®) as per the study protocol during the chemotherapy period Visit the research centers at specified intervals for checkups and assessments Record details of nausea, vomiting episodes, and any adverse reactions in a diary

Timeline

Start
2025-08-10
Primary completion
2026-10-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject medroxyprogesterone acetate Other / unclassified 5 ml Oral
Background Dexamethasone Small molecule 3.75 mg
Background Fosaprepitant Other / unclassified 150 mg
Background Ondansetron Other / unclassified 8 mg