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

NCT04430361 | Unknown Phase 2

• 1 other identifier: 2017098
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tumor; Chemotherapy-induced Nausea and Vomiting

Keywords

Megestrol; Tumor; Cisplatin; Chemotherapy-induced nausea and vomiting; Highly emetogenic chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  0 to 120 hours

• The adverse reactions related to antiemetic drugs

  1 mounth

• The score of quality of life of patients

  1 mounth

Study Arms (2)

Megestrol

EXPERIMENTAL

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; Drug: 5-HT3 receptor antagonist; Drug: dexamethasone

Control

OTHER

Palonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day

Drug: 5-HT3 receptor antagonist; Drug: dexamethasone

Interventions

Megestrol DRUG

160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.

Also known as: Megestrol acetate

Megestrol

5-HT3 receptor antagonist DRUG

5-HT3 receptor antagonist 2.5mg/iv

Control; Megestrol

dexamethasone DRUG

dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,

Control; Megestrol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Vomiting

Interventions

Megestrol; Megestrol Acetate; Serotonin 5-HT3 Receptor Antagonists; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Pregnadienetriols; Steroids, Fluorinated

Study Officials

• Suxia Luo

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Ning Li

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li

CONTACT

13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 12, 2020
• Study Start: September 7, 2018
• Primary Completion: December 30, 2020
• Study Completion: May 30, 2021
• Last Updated: June 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)