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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Tumor, Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Drug: Megestrol
* Drug: 5-HT3 receptor antagonist
* Drug: dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megestrol<br>Palonosetron 2.5mg, Dexamethasone 12mg on the first day, 8mg on the 2nd-4th day, Megestrol acetates 160mg orally every morning on the day of the beginning of chemotherapy for 10 days. | Drug: Megestrol<br>* 160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.<br>* Other names: Megestrol acetate;Drug: 5-HT3 receptor antagonist<br>* 5-HT3 receptor antagonist 2.5mg/iv<br>Drug: dexamethasone<br>* dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,<br>|
| Other: Control<br>Palonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day | Drug: 5-HT3 receptor antagonist<br>* 5-HT3 receptor antagonist 2.5mg/iv<br>Drug: dexamethasone<br>* dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The proportion of patients with grade 3-4 vomiting | The proportion of patients with grade 3-4 vomiting during chemotherapy | 0 to 120 hours | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor, Megestrol, Cisplatin, Chemotherapy-induced nausea and vomiting, Highly emetogenic chemotherapy