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Nano-crystalline Megestrol Acetate for Chemotherapy-induced Nausea and Vomiting

NCT07246070 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-11-24

No results posted yet for this study

Summary

The primary objective of this clinical study is to evaluate the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the prophylaxis of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.

The study population consists of gastric adenocarcinoma patients who are scheduled to receive their first course of moderately emetogenic chemotherapy (PD-1/PD-L1 immune checkpoint inhibitors combined with the CAPOX regimen). This study is divided into two phases. The first phase is a single-arm study design, with the primary objective of preliminarily assessing the efficacy and safety of nanocrystalline megestrol acetate combined with a 5-HT3 receptor antagonist for the full-course management of nausea and vomiting caused by moderately emetogenic chemotherapy drugs. The second phase will adopt a randomized, controlled, multicenter trial design. Based on the efficacy and safety data from the first phase, the investigators will optimize the trial design (primarily including the primary endpoint and sample size calculation) to evaluate the efficacy and safety of nanocrystalline megestrol acetate compared with dexamethasone, each combined with a 5-HT3 receptor antagonist, for the prevention of nausea and vomiting caused by moderately emetogenic chemotherapy drugs.

Conditions

  • Chemotherapy-Induced Nausea and Vomiting (CINV)

Interventions

DRUG

nanocrystalline megestrol acetate combined with ondansetron

nanocrystalline megestrol acetate (5 ml PO, qd, Day 1-Day 14), ondansetron (8 mg IV, qd, Day 1).

DRUG

dexamethasone combined with ondansetron

dexamethasone (8 mg IV, qd, Day 1), ondansetron (8 mg IV, qd, Day 1)

Sponsors & Collaborators

  • Henan Cancer Hospital

    collaborator OTHER_GOV

  • AIPING ZHOU

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-08-31
Completion
2026-12-31

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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 NCT07246070 on ClinicalTrials.gov