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| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard treatment | |
| Octreotide | Experimental | 3 monthly intramuscular injections of 10 mg Octreotide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octreotide Injection | Drug | 10 mg Sandostatin LAR intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight change in percent (%) | Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery | From baseline before surgery, at 1, 2, 3, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in gastrointestinal satiety hormone levels | 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. | Baseline, 7 days post-surgery and at 1, 2, 3 and 6 months |
| Changes in body composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Klevebro, MD, PhD | Center for Upper Gastrointestinal Cancer, Theme Cancer, Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital, Huddinge | Stockholm | Sweden |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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Parallell design with Control arm receiving standard treatment and Experimental arm receiving Octreotide treatment
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Body composition measured in percent (%) body fat (continuously) |
| Baseline, 1, 2, 3, and 6 months |
| Changes in nutritional status - PG-SGA | Nutritional status measured with the questionnaire PG-SGA | Baseline, 1, 2, 3, and 6 months |
| Changes in nutritional status - EORTC CAX24 | Nutritional status measured with the questionnaire EORTC CAX24 | Baseline, 1, 2, 3, and 6 months |
| Health-related Quality of Life - EORTC QLQ-C30 | Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 at baseline and at 1, 2, 3 and 6 months after randomization | Baseline, 1, 2, 3 and 6 months |
| Health-related Quality of Life - QLQ-OG25 | Health-related Quality of Life (HRQOL) measured using QLQ-OG25 at baseline and at 1, 2, 3 and 6 months after randomization | Baseline, 1, 2, 3 and 6 months |
| Percentage (of subjects) in need of enteral nutrition | Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube | Baseline, 1, 2, 3 and 6 months |
| Number and type of Adverse Events | Number and type of Adverse Events, including known AEs of Sandostatin LAR depot | From 7 days post-surgery and at 1, 2, 3 and 6 months (continuously) |
| Number of patients completing treatment | Number of patients completing treatment | From first treatment at 7 days post-surgery to last treatment at 2 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |