Status:
COMPLETED
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer
Lead Sponsor:
Fredrik Klevebro
Collaborating Sponsors:
Karolinska University Hospital
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 esophag...
Detailed Description
Dietary complications are the biggest problem for patients before, during and after surgical treatment. Improved multimodal therapy and centralization of treatment to highly specialized centers have l...
Eligibility Criteria
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.
Exclusion
- 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
Key Trial Info
Start Date :
June 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04871204
Start Date
June 16 2021
End Date
February 21 2024
Last Update
October 31 2024
Active Locations (1)
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1
Karolinska University Hospital, Huddinge
Stockholm, Sweden