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

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.

About this trial

Last updated 10 months ago

Study ID

GenSci158-101

Status

Not yet recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Started 8 months ago

What is this trial about?

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

What are the participation requirements?

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

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