Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04430361
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-05-26
Brief Title:
the Efficacy and Safety of 5-HT3 Receptor Antagonist Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Comparison of the Efficacy and Safety of 5-HT3 Receptor Antagonist Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy a Prospective Randomized Controlled Phase II Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
RECRUITING
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:
To compare the efficacy and safety of megestrol acetate dispersible tablets combined with 5-HT3 receptor antagonist and dexamethasone triple antiemetic regimen and 5-HT3 receptor antagonist and dexamethasone combined antiemetic regimen in the control of CINV induced by hyperemetic chemotherapy
Detailed Description:
120 patients with malignant tumors diagnosed by pathology or cytology and treated with highly emetogenic chemotherapy drugs containing cisplatin from September 2018 to December 2019 were selected The patients were randomly assigned to megestrol group megestrol acetate dispersible tablets5-HT3 receptor antagonistdexamethasone or control group 5-HT3 receptor antagonist dexamethasone at 11 The dosage of antiemetic drugs in the control group 5-HT3 receptor antagonist 25mg dexamethasone 12mg on the first day 8mg on the 2nd-4th day all were injected intravenously with 30min before chemotherapy for 5 days The patients in the megestrol acetate group were given megestrol acetate dispersible tablets on the basis of the control group 160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period 24-120 hours after the beginning of chemotherapy that is the proportion of complete remission no vomiting and no need for rescue treatment and complete prevention no nausea and vomitingThe secondary end point was the control ratio of nausea and vomiting in the acute phase 0-24 hours after the beginning of chemotherapy and the overall phase 0-120 hours after the beginning of chemotherapy the proportion of patients with grade 3-4 nausea and vomiting during chemotherapy the adverse reactions related to antiemetic drugs and the score of quality of life of patients in both groups before and after treatment
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?:
None
Is an FDA AA801 Violation?:
None