Status:
UNKNOWN
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
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Tumor
Chemotherapy-induced Nausea and Vomiting
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 dexame...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04430361
Start Date
September 7 2018
End Date
May 30 2021
Last Update
June 12 2020
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008