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

Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430361
• Other study ID #: 2017098
• Status: Recruiting
• Phase: Phase 2
• Start date: September 7, 2018
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2020
• Source: Henan Cancer Hospital
• Contact: Ning Li
• Phone: 13526501903
• Email: lining97[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 tablets+5-HT3 receptor antagonist+dexamethasone) or control group (5-HT3 receptor antagonist + dexamethasone) at 1:1. The dosage of antiemetic drugs in the control group: 5-HT3 receptor antagonist 2.5mg, 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 vomiting).The 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Tumor patients diagnosed by histopathology or cytology, as long as the chemotherapy with cisplatin is used, the amount of cisplatin is 60-80 mg/m2;

• Unlimited gender, age 18 to 70 years old;

• ECOG physical status score 0-1;

• The survival time is predicted to be more than 3 months;

• Bone marrow hematopoietic function was not significantly impaired (WBC=3.5109/L, ANC=1.5109/L, PLT=100109/L, Hb=100g/L);

• Biochemical examination AST / ALT = 2.5 times the upper limit of normal; bilirubin = 1.5 times the upper limit of normal; creatinine clearance = 60ml / min, normal ECG;

• Signing informed consent;

Exclusion Criteria:

• Women who are pregnant or breastfeeding, women of childbearing age who refuse to receive contraception;

• Brain metastasis;

• Combine all of the following serious or uncontrolled diseases that affect participation in the trial: Uncontrollable hypertension, history of unstable hypertension, or poor adherence to antihypertention drugs; Unstable angina; Symptomatic congestive heart failure; Myocardial infarction occurred within 6 months before enrollment; Severe uncontrollable arrhythmia; Uncontrollable diabetes; Active or uncontrollable infection; Intestinal paralysis, intestinal obstruction, interstitial pneumonia, active gastric ulcer; Subject to immunosuppressive therapy;

• Inability to understand or express informed consent;

• The investigator judged other conditions that were not suitable for clinical research.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Tumor
• Vomiting

Intervention

Drug:
• Megestrol
160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.
• 5-HT3 receptor antagonist
5-HT3 receptor antagonist 2.5mg/iv
• dexamethasone
dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of control of nausea and vomiting between the two groups during the delayed period	The main end point was the proportion of control of nausea and vomiting between the two groups during the delayed period chemotherapy	24 to120 hours
Secondary	The control ratio of nausea and vomiting in the acute phase and the overall phase	The control ratio of nausea and vomiting in the acute phase and the overall phase	0 to 120 hours
Secondary	The proportion of patients with grade 3-4 vomiting	The proportion of patients with grade 3-4 vomiting during chemotherapy	0 to 120 hours
Secondary	The adverse reactions related to antiemetic drugs	The adverse reactions related to antiemetic drugs of patients in both groups before and after treatment.	1 mounth
Secondary	The score of quality of life of patients	The score of quality of life of patients in both groups before and after treatment.	1 mounth