Clinical trial NCT04430361: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tumor
Chemotherapy-induced Nausea and Vomiting
Keywords: Megestrol
Tumor
Cisplatin
Chemotherapy-induced nausea and vomiting
Highly emetogenic chemotherapy
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of control of nausea and vomiting between the two groups during the delayed period
timeFrame: 24 to120 hours
Secondary outcomes:
measure: The control ratio of nausea and vomiting in the acute phase and the overall phase
timeFrame: 0 to 120 hours
measure: The proportion of patients with grade 3-4 vomiting
timeFrame: 0 to 120 hours
measure: The adverse reactions related to antiemetic drugs
timeFrame: 1 mounth
measure: The score of quality of life of patients
timeFrame: 1 mounth
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Suxia Luo
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Cancer Hospital
name: Ning Li
role: PRINCIPAL_INVESTIGATOR
References: