Octreotide treatment to improve nutritional recovery after surgery for patients with esophageal or gastric cancer, a prospective randomized open label phase II study - OTIS
Key facts
- Where
- Huddinge, SvédországSee the site
- Phase
- 2. fázis
Where in Svédország
- Karolinska University HospitalHuddinge, SvédországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karolinska University Hospital
- Trial code
- EU 2022-502745-98-00
- Record updated
- 2022. december 20.
- Original description
To determine if intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer.Read full original descriptionShow less
To determine if intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer.
Inclusion: 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.
Exclusion: Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study; Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine; Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery; Known or suspected allergy to octreotide; Bradycardia (defined as resting heart rate of under 60 beats per minute); Chronic obstructive pulmonary disease; Chronic liver disease; Kidney failure; Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; Pregnant or nursing female; Complications leading to restrictions in postoperative oral intake; Advanced comorbidity with ASA score III or more; Insulinoma.