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

A phase II study of megestrol acetate in patients receiving adjuvant chemotherapy for gastric cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0008479
Enrollment
54
Registered
2023-05-31
Start date
2022-11-14
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : During the period of adjuvant chemotherapy (6 months), chemotherapy and administration of Megestrol acetate 500mg/pack were administered concurrently. The dose of Megays is determined by the re

Sponsors

Pusan National University Yangsan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Planned chemotherapy cycle completion rate

Secondary

MeasureTime frame
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.

Countries

Korea, Republic of

Contacts

Public ContactSO YEON OH

Pusan National University Yangsan Hospital

manic2db@gmail.com+82-55-360-2369

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026