Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Rare Diseases

Esophageal Neoplasms

Stomach Neoplasms

Body Weight

Weight Loss

Malnutrition

Endocrine System Diseases

Body Weight Changes

Nutrition Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

All Drugs and Chemicals

Gastrointestinal Agents

Antineoplastic Agents

Hormones

Glucagon

Somatostatin

Glucagon-Like Peptide 1

Octreotide

Antineoplastic Agents, Hormonal

Double blind single dose placebo-octreotide crossover

Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating

0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating

Placebo

John V Reynolds, MCh, FRCS

Improvements to treatment strategies for patients upper gastrointestinal cancers have produced an increasing population of people who remain free from disease recurrence in the long term. Weight loss and nutritional problems are common among patients who attain long-term remission and cure after surgery for upper gastrointestinal cancers. However, the mechanisms underlying these problems are not well understood. In this study the investigators aim to determine whether reduced food intake after upper gastrointestinal surgery is caused by early satiety related to exaggerated post-prandial gut hormone responses.

This is a randomized, double-blind, placebo controlled, crossover study of the effect of 100μg octreotide SC on ad libitum food intake in patients free from complications or recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A comparator group of age, weight and gender matched subjects will be studied concurrently, and caloric intake and subjective symptom scores after administration of octreotide versus placebo among surgical and comparator subjects will be assessed.

Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer

Food Intake and Gut Hormone Release in Patients in Cancer Remission Who Have Undergone Upper Gastrointestinal Surgery

University College Dublin

University of Dublin, Trinity College

Göteborg University

St. James's Hospital, Ireland

Surgical Research Fellow

Blood and Lymph Conditions

Behaviors and Mental Disorders

Fatigue

Anemia

Pancreatic Neoplasms

Quality of Life

Pancreatic Cancer

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Hematinics

Chrysarobin

Epoetin Alfa

Patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Patients enrolled in the study will be randomized to receive either 40,000 units of placebo (saline) on day 1 and day 8. Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Epoetin Alfa group

Placebo group

Stephen R. Grobmyer, MD

This pilot study is looking at how well epoetin alfa, given in the immediate post-operative period, works in reducing anemia and the need for transfusions.

This is a pilot, single center, prospective, double blinded, randomized study comparing epoetin alfa versus placebo. Eligible patients will just have undergone a major abdominal operation for malignancy (esophagectomy, gastrectomy, partial hepatectomy, partial pancreatectomy, or low anterior resection of rectum) and have a post-operative hemoglobin greater than 8 g/dL and less than 11 g/dL on post-operative day #1. On post-operative day #1 patients enrolled in the study will be randomized to receive either 40,000 units of epoetin alfa or placebo. On post-operative day #8, the patients will receive an additional dose of epoetin alfa or placebo (depending on randomization assignment and Hgb level). Hemoglobin, hematocrit, reticulocyte count, reticulocyte hemoglobin, and immature reticulocyte count will be measured on days 1, 4, 8, and once between post-operative days 20 and 30. Pre-operatively and between post-operative days 20 and 30 patients will complete a quality of live assessment tool (FACT-An) to assess their fatigue related to anemia.

Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer

Placebo-Controlled Pilot Study to Assess the Post-Operative Administration of Epoetin Alfa on Patients Undergoing Abdominal or Pelvic Surgery for Malignancy

Ortho Biotech Clinical Affairs, L.L.C.

University of Florida

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer	NCT02385617	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition	Octreotide Placebo	18 Years - 100 Years	St. James's Hospital, Ireland
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer	NCT00294203	Anemia	Epoetin Alfa gr... Placebo group	18 Years -	University of Florida
Pilot Study of Epoetin Alfa for Patients Having Abdominal or Pelvic Surgery for Cancer	NCT00294203	Anemia	Epoetin Alfa gr... Placebo group	18 Years -	University of Florida

Spots Global Cancer Trial Database for digestive system surgical procedures