Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-29 @ 6:52 AM
Study NCT ID:
NCT07124195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nanocrystalline Megestrol for Managing Chemotherapy-Induced Nausea and Vomiting
Sponsor:
The First Affiliated Hospital of Xinxiang Medical College
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
A Randomized, Controlled, Multicenter Clinical Study on the Whole-Process Management of Nanocrystalline Megestrol in Preventing Chemotherapy-Induced Nausea and Vomiting This study enrolls subjects with malignant solid tumors who are initially planned to receive moderate to high emetogenic chemotherapy (MEC/HEC) drugs. It aims to explore the efficacy and safety of medroxyprogesterone acetate oral suspension (Meishiya®) in the whole-process management of preventing nausea and vomiting caused by single-day moderate to high emetogenic chemotherapy (MEC/HEC) drugs. The study adopts a multicenter, randomized controlled, open-label trial design, with a planned enrollment of 126 subjects. Enrolled subjects will be stratified based on the following factors: chemotherapy regimens (HEC vs MEC), gender (male vs female), and age (\<55 years vs ≥55 years).
The main interventions are as follows:
Prevention of CINV induced by HEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), 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) Control group: 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)
Prevention of CINV induced by MEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), 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) Control group: 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) The trial consists of a screening period, a treatment period, and a safety follow-up period. Eligible subjects after screening will be randomly assigned to the experimental group or the control group in a 1:1 ratio, receive drug treatment according to the trial protocol, and then complete corresponding follow-ups and examinations in accordance with the trial flow chart. During the study, if the researcher assesses that the subject really needs to use rescue antiemetic drugs, rescue treatment can be carried out according to clinical practice. The specific type, usage, dosage, and frequency of the drugs will be determined by the researcher.
The main interventions are as follows:
Prevention of CINV induced by HEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), 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) Control group: 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)
Prevention of CINV induced by MEC chemotherapy drugs (Cycles 1-2):
Experimental group: Medroxyprogesterone acetate oral suspension (Meishiya®) (administered from Day 1 to 21, 5 ml, once daily), 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) Control group: 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) The trial consists of a screening period, a treatment period, and a safety follow-up period. Eligible subjects after screening will be randomly assigned to the experimental group or the control group in a 1:1 ratio, receive drug treatment according to the trial protocol, and then complete corresponding follow-ups and examinations in accordance with the trial flow chart. During the study, if the researcher assesses that the subject really needs to use rescue antiemetic drugs, rescue treatment can be carried out according to clinical practice. The specific type, usage, dosage, and frequency of the drugs will be determined by the researcher.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: