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
Verified date | May 2020 |
Source | Henan Cancer Hospital |
Contact | Ning Li |
Phone | 13526501903 |
lining97[@]126.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Henan Cancer Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan Cancer Hospital |
China,
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 |
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