Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Behaviors and Mental Disorders

Stomach Neoplasms

Weight Loss

Esophageal Neoplasms

Body Weight

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Esophageal Cancer

Quality of Life

Antineoplastic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Octreotide

Antineoplastic Agents, Hormonal

3 monthly intramuscular injections of 10 mg Octreotide

10 mg Sandostatin LAR intramuscular injection

Octreotide Injection

Fredrik Klevebro, MD, PhD

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.

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 led to an increase in the number of patients surviving with chronic negative effects of esophageal surgery. The scientific state of knowledge about HRQOL and the symptoms of long-term survival of esophageal cancer is limited.

Patient-reported outcome measures (PRUs) are results reported by the patient himself, e.g. HRQOL, remaining symptoms, satisfaction with health care and other problems in daily life. These results have rarely been of importance before but are now increasingly crucial in the evaluation of treatment. It is no longer just about survival for patients with cancer of the esophagus. 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.

Our hypothesis is that intramuscularly administered octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer and that it may improve postoperative health related quality of life. This study aims to investigate if postoperative eating problems can be reduced by treatment with octreotide in this patient group.

In the first part of the study: Sub study 1, safety, tolerability and feasibility of octreotide treatment will be investigated. Twenty patients diagnosed with esophageal or gastric cancer will receive three monthly injections of 10 mg of Sandostatin LAR depot. Patients will be followed up at 1, 2, 3 and 6 months for monitoring of safety blood parameters, changes in weight, health-related quality of life and adverse events.

In the second part of the study: Sub study 2, efficacy of treatment with octreotide will be studied. 152 patients diagnosed with esophageal or gastric cancer will be randomized 1:1 to post-surgical treatment with octreotide or no treatment. Patients in the active arm will receive three monthly injections of 10 mg of Sandostatin LAR depot. All patients will be followed up at 1, 2, 3 and 6 months in the same manner as in Sub study 1. In this study part gastrointestinal satiety hormones and nutritional evaluation associated quality of life will be studied in addition to body weight, body composition and health-related quality of life.

Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment

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

Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery

Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days post-surgery and after 1, 2, 3 and 6 months.

Body composition measured in percent (%) body fat (continuously)

Nutritional status measured with the questionnaire PG-SGA

Nutritional status measured with the questionnaire EORTC CAX24

Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 at baseline and at 1, 2, 3 and 6 months after randomization

Health-related Quality of Life (HRQOL) measured using QLQ-OG25 at baseline and at 1, 2, 3 and 6 months after randomization

Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube

Number and type of Adverse Events, including known AEs of Sandostatin LAR depot

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients With Esophageal or Gastric Cancer	NCT04871204	Esophageal Canc... Gastric Cancer	Octreotide Inje...	18 Years -	Karolinska University Hospital
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients With Esophageal or Gastric Cancer	NCT04871204	Esophageal Canc... Gastric Cancer	Octreotide Inje...	18 Years -	Karolinska University Hospital
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients With Esophageal or Gastric Cancer	NCT04871204	Esophageal Canc... Gastric Cancer	Octreotide Inje...	18 Years -	Karolinska University Hospital
Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients With Esophageal or Gastric Cancer	NCT04871204	Esophageal Canc... Gastric Cancer	Octreotide Inje...	18 Years -	Karolinska University Hospital

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