Is it possible to improve the nutritional recovery with a medicine called Sandostatin after surgery for esophageal or gastric cancer?
- Conditions
- ndesired weight loss after operation for esophageal or gastric cancerMedDRA version: 21.1Level: PTClassification code 10027415Term: Metabolic abnormality managementSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2019-001200-38-SE
- Lead Sponsor
- Karolinska Universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 172
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>•To determine if octreotide treatment affects body composition<br>•To determine if octreotide treatment affects postoperative health related quality of life<br>•To study if postoperative eating problems can be reduced by intramuscular administration of octreotide<br>•To study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer<br>;Primary end point(s): •Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously).<br>;Timepoint(s) of evaluation of this end point: 1,2,3 and 6 months after surgery
- Secondary Outcome Measures
Name Time Method