PloS one · 2026
Protocol of the PANEM trial: A randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing PANcreatic EnzyMes versus placebo in adults after gastrectomy.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Thomas Kevin, Ackmann Charlotte, Schmiedeknecht Anett, Scheibe Kathrin, Kleemann Tobias, Ardelt Michael, Dondorf Felix, Radulova-Mauersberger Olga, Kuvendjiska Jasmina, Hipp Julian, Jansen-Winkeln Boris, Bley Thomas, Wetzold Ulrike, Sporn Judith, Peters Franziska, Téoule Patrick, Birgin Emrullah, Petroff David, Hoffmeister Albrecht
Аннотация
BACKGROUND: Patients after partial or total gastrectomy suffer from malnourishment and diminished quality of life (QOL). Due to altered physiological processes after gastric surgery, coordination between chyme and digestive enzymes produced by the pancreas is affected in many ways, finally leading to maldigestion and malabsorption. These in turn promote various symptoms such as discomfort or steatorrhea. Supplementation of digestive enzymes during food intake may improve digestion and decrease nutrition-related abdominal symptoms, finally leading to higher QOL. To date, trials examining the role of digestive enzyme supplementation in patients with gastrectomy are lacking.
METHODS: We designed a randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing QOL after 6 months of oral digestive enzyme supplementation vs. placebo in a sample of 188 patients after partial or total gastrectomy. Digestive enzymes or placebo are taken orally with the meals. Cancer specific QOL (physical sub-score from EORTC-QLQ-C30) at six months is the primary outcome. Secondary outcomes include other measures of QOL, weight loss, use of supplemental nutrition, and laboratory measurements related to malnutrition and metabolism.
DISCUSSION: This trial will help assess using digestive enzymes in patients with partial or total gastrectomy.
TRIAL REGISTRATION: EU Trial Number: 2022-501944-14-00. Clinical Trial Number: NCT06058442 (Registration date: 09/08/2023).
METHODS: We designed a randomized, phase III, parallel-arm, placebo-controlled, double-blind, multi-center superiority trial comparing QOL after 6 months of oral digestive enzyme supplementation vs. placebo in a sample of 188 patients after partial or total gastrectomy. Digestive enzymes or placebo are taken orally with the meals. Cancer specific QOL (physical sub-score from EORTC-QLQ-C30) at six months is the primary outcome. Secondary outcomes include other measures of QOL, weight loss, use of supplemental nutrition, and laboratory measurements related to malnutrition and metabolism.
DISCUSSION: This trial will help assess using digestive enzymes in patients with partial or total gastrectomy.
TRIAL REGISTRATION: EU Trial Number: 2022-501944-14-00. Clinical Trial Number: NCT06058442 (Registration date: 09/08/2023).