Clinical trial · Interventional
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
NCT04871204CI-TRIAL-00082113OTIScompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Octreotide Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard treatment
- type
- EXPERIMENTAL
- label
- Octreotide
- description
- 3 monthly intramuscular injections of 10 mg Octreotide
- interventionNames
- Drug: Octreotide Injection
Primary outcomes (1)
- measure
- Weight change in percent (%)
- timeFrame
- From baseline before surgery, at 1, 2, 3, and 6 months
- description
- Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.