Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low dose of Megestrol Acetate Oral Suspension combined with standard therapy, Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy, High dose of Megestrol Acetate Oral Suspension combined with standard therapy, Megestrol Acetate Oral Suspension Placebo combined with standard therapy.
- Who it may be relevant to
- Registry conditions: Efficacy, Safety, Megestrol Acetate, Adult Subject. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
Overview
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.
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.
Primary outcome measures
- Proportion of Subjects Experiencing No Nausea During 0-168 Hours After Initiation of the First Chemotherapy Cycle [Time frame: 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 [Time frame: From 0 to 120 Hours After Initiation of Chemotherapy]
Secondary outcome measures (1)
- 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 [Time frame: From 0 to 168 Hours After Initiation of Chemotherapy]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years, regardless of sex
- Histologically or cytologically confirmed lung cancer
- Expected survival ≥ 3 months
- Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating
- Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements/restrictions 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07130617 · GenSci158-101