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

June 10, 2020 updated by: Henan Cancer Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Megestrol
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
160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.
Other Names:
  • Megestrol acetate
Drug: 5-HT3 receptor antagonist
5-HT3 receptor antagonist 2.5mg/iv
Drug: dexamethasone
dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,
Other: Control
Palonosetron 2.5mg, Dexamethasone12mg on the first day, 8mg on the 2nd-4th day
Drug: 5-HT3 receptor antagonist
5-HT3 receptor antagonist 2.5mg/iv
Drug: dexamethasone
dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of control of nausea and vomiting between the two groups during the delayed period
Time Frame: 24 to120 hours
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The control ratio of nausea and vomiting in the acute phase and the overall phase
Time Frame: 0 to 120 hours
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
Time Frame: 0 to 120 hours
The proportion of patients with grade 3-4 vomiting during chemotherapy
0 to 120 hours
The adverse reactions related to antiemetic drugs
Time Frame: 1 mounth
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
Time Frame: 1 mounth
The score of quality of life of patients in both groups before and after treatment.
1 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017098

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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