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Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy

NCT07130617 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-08-19

No results posted yet for this study

Summary

To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients

Conditions

  • Efficacy
  • Safety
  • Megestrol Acetate
  • Adult Subject

Interventions

DRUG

Low dose of Megestrol Acetate Oral Suspension combined with standard therapy

A single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days.

DRUG

Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy

A single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days.

DRUG

High dose of Megestrol Acetate Oral Suspension combined with standard therapy

A single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.

DRUG

Megestrol Acetate Oral Suspension Placebo combined with standard therapy

A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.

Sponsors & Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, PHD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07130617 on ClinicalTrials.gov