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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-29

Study Completion Date

2026-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Efficacy Safety Megestrol Acetate Adult Subject

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Low dose of Megestrol Acetate Oral Suspension

Group Type EXPERIMENTAL

Low dose of Megestrol Acetate Oral Suspension combined with standard therapy

Intervention Type DRUG

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

Medium dose of Megestrol Acetate Oral Suspension

Group Type EXPERIMENTAL

Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy

Intervention Type DRUG

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

High dose of Megestrol Acetate Oral Suspension

Group Type EXPERIMENTAL

High dose of Megestrol Acetate Oral Suspension combined with standard therapy

Intervention Type DRUG

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

Megestrol Acetate Oral Suspension Placebo

Group Type ACTIVE_COMPARATOR

Megestrol Acetate Oral Suspension Placebo combined with standard therapy

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

1\. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No