NCT04871204CompletedPhase 2
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer, a Prospective Randomized Open Label Phase II Study - OTIS
Source: ClinicalTrials.gov · Last updated 31 Oct 2024
Brief summary (registry, in English)
The aim of the study is to clarify whether octreotide therapy can reduce undesired postoperative weight loss, increase health-related quality of life and improve the appetite after surgery for esophageal or gastric cancer.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 23 Apr 2021
- Start date
- 16 Jun 2021
- Primary completion date
- 21 Feb 2024
- Lead sponsor
- Fredrik Klevebro
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04871204
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 16 Jun 2021 to the primary completion date, 21 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine
- Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study
Other illness
- Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
- Bradycardia (defined as resting heart rate of under 60 beats per minute)
- Chronic obstructive pulmonary disease
- Chronic liver disease
- Kidney failure
- Known or suspected allergy to octreotide
Other
- Complications leading to restrictions in postoperative oral intake
- Advanced comorbidity with ASA score III or more
- Insulinoma
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Pregnant or nursing female
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska University Hospital Huddinge Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.