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

Not Applicable

Not yet recruiting

• Conditions: Efficacy; Safety; Megestrol Acetate; Adult Subject
• Interventions: Drug: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy; Drug: Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy; Drug: High dose of Megestrol Acetate Oral Suspension combined with standard therapy; Drug: Megestrol Acetate Oral Suspension Placebo combined with standard therapy

• Registration Number: NCT07130617
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

This multicenter, randomized, double-blind, placebo-controlled parallel-group study evaluates the efficacy, safety, and pharmacokinetic profile of megestrol acetate oral suspension in preventing nausea and vomiting induced by highly emetogenic chemotherapy. The trial plans to enroll 132 chemotherapy-naive malignant solid tumor patients scheduled to undergo initial single-day highly emetogenic chemotherapy regimens.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-09-29
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. Age ≥ 18 years, regardless of sex

2. Histologically or cytologically confirmed lung cancer

3. Expected survival ≥ 3 months

4. Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating

5. Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions Exclusion Criteria

6. Received or scheduled to receive concurrent radiotherapy within 7 days prior to enrollment through Day 1-8 of treatment 2. Systemic corticosteroid therapy or sedating antihistamines within 7 days prior to enrollment 3. Poorly controlled serous cavity effusions (pleural/peritoneal/pericardial) 4. Severe cardiovascular diseases within 3 months prior to enrollment 5. Participation in other clinical trials within 30 days prior to enrollment

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose of Megestrol Acetate Oral Suspension	Low dose of Megestrol Acetate Oral Suspension combined with standard therapy	-
Medium dose of Megestrol Acetate Oral Suspension	Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy	-
High dose of Megestrol Acetate Oral Suspension	High dose of Megestrol Acetate Oral Suspension combined with standard therapy	-
Megestrol Acetate Oral Suspension Placebo	Megestrol Acetate Oral Suspension Placebo combined with standard therapy	-

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle	From 0 to 168 Hours After Initiation of Chemotherapy
Proportion of Subjects Experiencing No Nausea During 0-120 Hours After Initiation of the First Chemotherapy Cycle	From 0 to 120 Hours After Initiation of Chemotherapy

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Complete Response (No significant nausea, No vomiting, etc. ) in the Acute, Delayed, Extended Delayed, 0-120 h, and 0-168 h Phases During the First Chemotherapy Cycle	From 0 to 168 Hours After Initiation of Chemotherapy

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China