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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low dose of Megestrol Acetate Oral Suspension combined with standard therapy

    Drug

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

  • Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy

    Drug

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

  • High dose of Megestrol Acetate Oral Suspension combined with standard therapy

    Drug

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

  • Megestrol Acetate Oral Suspension Placebo combined with standard therapy

    Drug

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

Treatment groups

132 Participants
are divided into 4 treatment groups
Group A: Low dose of Megestrol Acetate Oral SuspensionExperimental treatment 1 intervention
Group B: Medium dose of Megestrol Acetate Oral SuspensionExperimental treatment 1 intervention
Group C: High dose of Megestrol Acetate Oral SuspensionExperimental treatment 1 intervention
Group D: Megestrol Acetate Oral Suspension PlaceboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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 outcomes

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

Other outcomes

Sponsors and contacts

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