A phase II study of appetite stimulant megestrol acetate in patients receiving chemotherapy after gastric cancer surgery

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008479
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1) 19 years of age or older
2) Radical surgery for gastric cancer (R0 resection)
3) Stage II or III
4) Patients planning to receive adjuvant chemotherapy
5) Weight loss = 5% in the last 6 months
6) Appetite NRS score = 4
7) The patient accepts weight loss as a problem
8) I fully understand the informed consent and sign it by hand
9) A person who understands the clinical trial contents, is cooperative with the trial process, and is judged to be able to participate until the end of the study

Exclusion Criteria

1) Pregnant or lactating women
2) For gastric cancer, palliative surgery was performed instead of radical complete resection (R1 or R2 surgery).
3) Obesity (BMI =25 Kg/m2)
4) If there is a history of deep vein thrombosis or pulmonary thromboembolism
5) When it is judged that the researcher cannot comply with the requirements of the clinical trial protocol or has no intention to comply.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Planned chemotherapy cycle completion rate

Secondary Outcome Measures

Name	Time	Method
1) Relative dose intensity of chemotherapy, 2) Maximum chemotherapy dose reduction, 3) Quality of life (EQ5D), 4) Weight change, 5) Appetite NRS, 6) Adverse reactions, 7) Total prescription amount of megestrol.