Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients With Esophageal or Gastric Cancer

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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 esophageal or gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fredrik Klevebro
• Collaborator: Karolinska University Hospital
• Treatments: Octreotide

Criteria

Inclusion Criteria:

1. Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer

2. Gastrectomy or esophagectomy with curative intent

3. ≥18 years of age

4. Signed informed consent

5. Able to comply with the procedures of the study protocol, in the opinion of the investigator

6. 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 Criteria:

1. Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery

2. Complications leading to restrictions in postoperative oral intake

3. Advanced comorbidity with ASA score III or more

4. Bradycardia (defined as resting heart rate of under 60 beats per minute)

5. Chronic obstructive pulmonary disease

6. Chronic liver disease

7. Insulinoma

8. Kidney failure

9. Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine

10. Known or suspected allergy to octreotide

11. Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation

12. Pregnant or nursing female

13. Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study