Octreotide treatment to improve nutritional recovery after surgery for patients with esophageal or gastric cancer, a prospective randomized open label phase II study - OTIS

Conditions

Esophageal and gastric cancer

Brief summary

Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously).

Detailed description

Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days (±2 days) post-surgery and after 1 (±4 days), 2(±4 days), 3(±4 days), and 6 (±4 days) months., Body composition measured in percent (%) body fat (continuously) and with the questionnaires PG-SGA and EORTC CAX24., Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 and QLQ-OG25, including esophageal cancer specific symptoms, at baseline and at 1, 2, 3 and 6 months after randomization., Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube, Number and type of Adverse Events, including known AEs of Sandostatin LAR depot, such as biliary abnormalities, injection-site pain, nausea, abdominal pain, fatigue, headache, hyperglycemia, back pain, constipation or vomiting, dizziness, sinus bradycardia, pruritus, upper respiratory tract infection, myalgia, flatulence, arthropathy, rash, generalized pain, sinusitis, conduction abnormalities, hypoglycemia, and arrhythmia., Number of patients completing treatment.

Related papers

No related papers found yet.

Interventions

DRUGSandostatin LAR 10 mg pulver och vätska till injektionsvätska

DRUGsuspension

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously).	—

Secondary

Measure	Time frame
Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days (±2 days) post-surgery and after 1 (±4 days), 2(±4 days), 3(±4 days), and 6 (±4 days) months., Body composition measured in percent (%) body fat (continuously) and with the questionnaires PG-SGA and EORTC CAX24., Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 and QLQ-OG25, including esophageal cancer specific symptoms, at baseline and at 1, 2, 3 and 6 months after randomization., Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube, Number and type of Adverse Events, including known AEs of Sandostatin LAR depot, such as biliary abnormalities, injection-site pain, nausea, abdominal pain, fatigue, headache, hyperglycemia, back pain, constipation or vomiting, dizziness, sinus bradycardia, pruritus, upper respiratory tract infection, myalgia, flatulence, arthropathy, rash, generalized pain, sinus	—

Measure

Time frame

Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days (±2 days) post-surgery and after 1 (±4 days), 2(±4 days), 3(±4 days), and 6 (±4 days) months., Body composition measured in percent (%) body fat (continuously) and with the questionnaires PG-SGA and EORTC CAX24., Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 and QLQ-OG25, including esophageal cancer specific symptoms, at baseline and at 1, 2, 3 and 6 months after randomization., Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube, Number and type of Adverse Events, including known AEs of Sandostatin LAR depot, such as biliary abnormalities, injection-site pain, nausea, abdominal pain, fatigue, headache, hyperglycemia, back pain, constipation or vomiting, dizziness, sinus bradycardia, pruritus, upper respiratory tract infection, myalgia, flatulence, arthropathy, rash, generalized pain, sinus

—

Countries

Sweden

Outcome results

None listed