Undesired weight loss after operation for esophageal or gastric cancer MedDRA version: 21.1 Level: PT Classification code 10027415 Term: Metabolic abnormality management System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Sandostatin LAR 10mg
Pharmaceutical Form: Powder and solvent for suspension for injection
CAS Number: 79517-01-4
Other descriptive name: OCTREOTIDE ACETATE
Concentration unit: mg milligram
Sponsors
Karolinska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer •Gastrectomy or esophagectomy with curative intent •=18 years of age •Signed informed consent •Able to comply with the procedures of the study protocol, in the opinion of the investigator •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. A negative pregnancy test is required for participation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 86
Exclusion criteria
Exclusion criteria: •Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery •Complications leading to restrictions in postoperative oral intake •Advanced comorbidity with ASA score III or more •Bradycardia (defined as resting heart rate of under 60 beats per minute) •Chronic obstructive pulmonary disease •Chronic liver disease •Insulinoma •Kidney failure •Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine. •Known or suspected allergy to octreotide •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation •Pregnant or nursing female •Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if intramuscular administered Octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer.;Secondary Objective: •To study if octreotide treatment affects the levels of gastrointestinal satiety hormones •To determine if octreotide treatment affects body composition •To determine if octreotide treatment affects postoperative health related quality of life •To study if postoperative eating problems can be reduced by intramuscular administration of octreotide •To study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer ;Primary end point(s): •Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously). ;Timepoint(s) of evaluation of this end point: 1,2,3 and 6 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •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. ;Timepoint(s) of evaluation of this end point: 1,2,3 and 6 months after surgery | — |
Countries
Sweden
Contacts
Public ContactFoU-enheten PO Övre Buk B75
Karolinska Universitetssjukhuset, FoU-enheten PO övre buk B75
Outcome results
None listed