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NOT YET RECRUITING
NCT07124195
PHASE3

Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting

Sponsor: The First Affiliated Hospital of Xinxiang Medical College

View on ClinicalTrials.gov

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

Official title: A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2025-08-10

Completion Date

2026-12-31

Last Updated

2025-08-15

Healthy Volunteers

No

Interventions

DRUG

Medroxyprogesterone acetate oral suspension

Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily)

COMBINATION_PRODUCT

high antiemetic regimen

Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily), Fosaprepitant (administered on Day 1, 150 mg, once daily)

COMBINATION_PRODUCT

moderate antiemetic regimen

Ondansetron Injection (administered on Day 1, 8 mg, once daily), Dexamethasone Tablets (administered on Day 1, 12 mg, once daily; administered from Day 2 to 4, 3.75 mg, twice daily)

Locations (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China