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 cancerMedDRA version: 21.0Level: LLTClassification code: 10015362Term: Esophageal cancer Class: 10029104MedDRA version: 21.1Level: PTClassification code: 10017758Term: Gastric cancer Class: 100000004864Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2022-502745-98-00
- Lead Sponsor
- Karolinska University Hospital
- 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, only after A. leaving a negative result on a highly sensitive pregnancy test, B. are using a highly effective method of contraception during treatment, and C. throughout the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly (a list of approved methods is provided in appendix D). An additional pregnancy test is to be provided at end of exposure.
Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery, 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., 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
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 intramuscularly 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).
- Secondary Outcome Measures
Name Time Method