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

Wasting Syndrome

Cachexia

Syndrome

Thinness

Metabolic Diseases

Anti-Inflammatory Agents

Secretagogues

Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS) receptor. When administered peripherally it stimulates growth hormone secretion, food intake, triggers a positive energy balance, produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects

As starting dose the investigators choose a dose level which was shown in our last study to be safe in human beings, i.e. 8μg/kg intravenously. With an assumed bioavailability of 25% of subcutaneously administered ghrelin the corresponding dose for dose level 1 is therefore 32 μg/kg. In the first 4 dose levels for each subsequent dose level the dose is increased by 50% compared to the previous one, from the 5th dose level onwards the increase is 25%: Dose level 1 = 32 μg/kg Dose level 2 = 48 μg/kg Dose level 3 = 72 μg/kg Dose level 4 = 108 μg/kg Dose level 5 = 135 μg/kg Dose level 6 = 169 μg/kg Dose level 7 = 211 μg/kg The investigators define the maximum tolerable dose as 20mg ghrelin (equivalent to 5ml) for reasons of the high drug volume to be administered subcutaneously.

ghrelin

Florian Strasser, PD Dr. MD

Cachexia, a condition of severe malnutrition, negative nitrogen balance, muscle wasting, weight loss, and anorexia, is a frequent affecting more than 80% of patients in advanced cancer disease causing a high burden on patients and their families. Nutritional, pharmacological, and behavioural interventions for cancer-related ACS and associated symptoms have, despite the importance for cancer care, limited effect on only a minority of patients. New strategies are required.

Ghrelin, a 28 amino acid peptide discovered in 1999, is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue (GHS) receptor. When administered peripherally it stimulates growth hormone secretion, food intake, triggers a positive energy balance, produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects. A recently completed trial on intravenous ghrelin in advanced cancer patients with ACS reports good tolerability and safety of single intravenous application of 2 and 8μg/kg Ghrelin.

Given the facts that ACS is a major burden in patients suffering advanced cancer disease and ghrelin is a major signal for stimulating food intake, promoting positive energy balance and weight gain and may have anti-inflammatory effect it remains to be determined whether the administration of ghrelin will have a positive clinical effect on cancer anorexia/ cachexia syndrome ACS. The next logical clinical development step is a proper dose-finding study of twice daily subcutaneous administration and proof-of-concept of main outcomes.

Individual Dose-escalated Bi-daily Subcutaneously (sc) Ghrelin in Cancer Cachexia: a Phase I/II Study

Individual Dose-escalated Bi-daily sc Ghrelin in Cancer Cachexia: a Phase I/II Study

Bachem

Cantonal Hospital of St. Gallen

Associate Professor Clinic for Oncology and Hematology

Infections

Carcinoma

Obesity

Liver Cirrhosis

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis C

Hepatitis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Diseases

Adenocarcinoma

Liver Neoplasms

Communicable Diseases

Blood-Borne Infections

Hepatitis, Viral, Human

Virus Diseases

Flaviviridae Infections

RNA Virus Infections

Hematinics

Liver Extracts

Embospheres Microspheres as artificial embolic agent for left gastric artery embolization

Via a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embosphere Microspheres beads) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry

Embospheres Microspheres

Keith Pereira, MD

Kirubahara Vaheesan, MD

Alex Befeler, MD

Mustafa Nazzal, MD

Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor and has a grave prognosis. Obesity is an epidemic in the US.Patients with HCC and obesity are not candidates for liver transplantation, depriving them of the best option for cure from HCC.

Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with cirrhosis and HCC who are not transplant candidates due to morbid obesity, leads to clinically significant weight loss with eligibility for liver transplantation.

Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated that, by the year 2030, 38% of the world's adult population will be overweight and another 20% obese .An expert panel convened by the NIH stated that for the first time in history, the steadily improving worldwide life expectancy could level off or even decline, as the result of increasing obesity.

Liver cirrhosis with portal hypertension and HCC:

The problem: Hepatocellular carcinoma (HCC) is the most common primary malignant liver tumor seen in the setting of cirrhosis, which itself can be of varying etiology. NASH as cause for liver cirrhosis and HCC has been growing in last decade. Although Hepatitis C is currently the most common indication for liver transplant, longitudinal trends show that NASH has a trajectory to become the most common.

Current options in management: Patients who develop HCC in the context of underlying chronic liver disease complicated by portal hypertension are not candidates for resection therapy; rather, orthotopic liver transplantation (OLT) offers the best option for cure and long-term survival. Most transplant centers have strict criteria for OLT; one of the most common is a BMI \< 35 kg/m2. Most NASH patients with HCC will have a high BMI. Unfortunately in presence of HCC these patients have a very limited time to lose enough weight to qualify to be listed. Lifestyle modification and medical therapies are relatively ineffective. Bariatric surgery is contraindicated in patients with portal hypertension due to significant increase in post-operative mortality, more relevant in patient listed to liver transplantation.

Thus a safe and effective minimally invasive option is needed. Based on currently available data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of about 10.5% in 3-6 months, with a high safety profile. In patients who have cirrhosis and portal hypertension with HCC and who are not transplant candidates due to morbid obesity , appropriate and timely weight loss of 10.5% in 3-6 months by performing LGAE may allow them to be listed and transplanted before their cirrhosis and tumor reaches an inoperable stage( within Milan criteria). In patients with HCC, the procedure can be performed concurrently with the procedure of Trans arterial chemoembolization which is commonly used in down staging HCC to Milan criteria.

Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation

A Single Center, Non-randomized Study to Evaluate the Safety and Efficacy of Left Gastric Artery Embolization in Obese Patients With Hepatocellular Carcinoma to Achieve Appropriate Weight Loss That May Allow Them to be Transplanted

Total body weight loss \> 10 % in 12 months

Improvement in abdominal circumference measured in centimeters (cm)

Improvement in blood pressure measured in mmHg

Reduction in serum Ghrelin and other serum obesity hormones(Leptin, GLP-1, PYY) measured in pg/mL

Reduction in serum glucose levels measured as mg/dL

Reduction in HbA1c measures as percentage(%)

Improvement in lipid profile measured as mg/dL

Symptoms: pain, nausea, vomiting ;Adverse effects: Expected and unexpected

Photos and clinical reports analyzed for ulcers

Weight loss to lower BMI\< 35 kg/m2 to be eligible for transplant or receive a new liver transplant.

Proportion of patients that achieved appropriate weight reduction to be listed for transplantation.

St. Louis University

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Pancreatic Cancer

Blood draw

J Marc Pipas, MD

The primary outcome measure for this study is plasma ghrelin level.

The primary outcome measure for this study is plasma ghrelin level, and the two primary comparison are:

* Patients with cachexia versus patients without cachexia
* Patients with cachexia versus healthy controls

Ghrelin Levels in Pancreatic Cancer Patients

Assessment of Plasma Ghrelin Levels in Patients With Pancreatic Cancer

Dartmouth-Hitchcock Medical Center

Serial assessment:

Fasting gut hormones, post-prandial gut hormone response to a standardized 400kcal meal

Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.

Standardized 400kcal semi-liquid meal

Surgery is the cornerstone of treatment for patients with oesophageal or gastric cancer, but while surgical removal of the tumour (oesophagectomy or gastrectomy) may offer the best chance of cure, these are major operations associated with specific long term complications. Weight loss and poor nutrition are relatively common problems among patients who attain long-term cancer remission and cure after surgery. The mechanisms underlying these problems are not well understood and therefore treatment options are limited.

The investigators research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone upper gastrointestinal surgery. These chemical messengers play a role in signalling the feeling of fullness during and after a meal (satiety). Understanding the mechanisms involved in increased gut hormone secretion after these operations may allow us to use certain medications to block gut hormone release and hence reduce satiety allowing patients to eat more, regain weight and prevent nutritional complications after surgery.

Exaggerated post-prandial satiety gut hormone responses following oesophagectomy have, however, only been established cross-sectionally and therefore the time course for development of increased gut hormone secretion is unknown. Data collected from this study will provide important information about optimal timing of therapeutic intervention in this patient group, while offering mechanistic insights with regard to the pathophysiologic process underlying post-operative early satiety.

Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer

Dong-Kyu Jin, M.D.

According to Seoul cancer registry data (2000), cancer became the leading cause of death in Korea, accounting for 23.9% of all deaths and gastric cancer is the most prevalent malignant neoplasm, comprising 20.8% of all cancers. Korea and some part of Asian countries have the highest incidence of gastric cancer in the world. Therefore, gastrectomy became one of the most common cancer operation in Korea. Thanks to early detection and intervention, the mortality of early gastric cancer drops dramatically and is now believed to be one of the most curable diseases among all the cancers. However, after successful operation and the declaration of cure of the stomach cancer, the patients are left without stomach for all his remaining life. If the patients lose most of his stomach tissue, there are several problems, which include loss of reservoir function for food and indigestion. Besides, loss of appetite is of the paramount importance because the stomach is an important endocrine organ controlling the appetite via gut-brain axis and the main axis is through a hormone called ghrelin, the only orexigenic hormone in human.

Because ghrelin is mainly secreted by the fundus and body, operations such as laryngoscopic Roux-en-Y gastric bypass: (LRYGBP), laryngoscopic-adjustable silicone gastric banding (LASGB) virtually abolish the ghrelin expressing cells. Thus loss of appetite is an inevitable consequence. Then what happens of the plasma ghrelin after Billoth surgery (standard gastric cancer operation) which removes antrum and body of the stomach where ghrelin expressing cells are relatively less distributed? Also puzzling is the fact that after surgery some patients start to gain weight while others continue to lose weight and appetite. Are there ghrelin-expressing cell hyperplasia in the patients who start to gain weight?

The gastrectomy operation which is performed at the investigators institute is Billoth I or II operation. The operation virtually eliminate the half of the body and most of the antrum. If fundus is involved also, proximal gastrectomy is the operation of the choice. Most of the patients who have these operations will lose weight during 1-3 months after surgery, thereafter slowly recover. However, the mechanism of the weight recovery has not been elucidated so far.

To elucidate the mechanism of re-gaining body weight and possible ghrelin expressing cell hyperplasia, the investigators designed the prospective study to investigate the stomach tissue as well as plasma ghrelin in the patients who are going to have Billoth surgery. The items to be investigated include plasma for hormones (ghrelin, leptin, insulin, CCK, PYY), stomach tissue for ghrelin, diet evaluation and body weight (body mass index) changes for 7 months after gastrectomy.

The investigators hope that their study will reveal the valuable information on the body weight recovery and appetite issue. So far the issue of the stomach cancer patients was related to survival issue. However, to lead a comfortable life the quality of life is also very important. The investigators approach will hint the way of surgery which will benefit the patients to live a happy life.

The below is the items to be included in the study.

* diet evaluation: standard three-day diet evaluation table (Dept. of Nutrition)
* body weight and height: BMI .
* ELISA for plasma ghrelin, leptin, insulin, CCK, PYY: whole blood 5 ml in EDTA tube (sampling time: during fasting, around 8 AM-9 AM if possible)
* two biopsy specimen: the same site. Fundus. One for ELISA and one for IHC
* ELISA for tissue ghrelin: frozen in liquid nitrogen
* immunohistochemistry for ghrelin producing cell hyperplasia, Paraffin block cutting for immunohistochemistry

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
Individual Dose-escalated Bi-daily Subcutaneously (sc) Ghrelin in Cancer Cachexia: a Phase I/II Study	NCT00933361	Advanced Cancer Cachexia	ghrelin	18 Years -	Cantonal Hospital of St. Gallen
Individual Dose-escalated Bi-daily Subcutaneously (sc) Ghrelin in Cancer Cachexia: a Phase I/II Study	NCT00933361	Advanced Cancer Cachexia	ghrelin	18 Years -	Cantonal Hospital of St. Gallen
Bariatric Embolization of Arteries in Obese Patients With HCC to Allow Salvage Liver Transplantation	NCT02935478	Obesity Weight Loss Body Weight Hepatocellular ... HCC Hepatitis C Cirrhosis	Embospheres Mic...	18 Years - 65 Years	St. Louis University
Ghrelin Levels in Pancreatic Cancer Patients	NCT00225745	Pancreatic Canc...	Blood draw	18 Years -	Dartmouth-Hitchcock Medical Center
Longitudinal Assessment of Gut Hormone Secretion Following Upper Gastrointestinal Surgery for Cancer	NCT02385630	Esophageal Neop... Stomach Neoplas... Weight Loss Malnutrition	Standardized 40...	18 Years -	St. James's Hospital, Ireland
Obestatin Change in Distal Gastrectomy	NCT00822718	Gastric Cancer ...		18 Years -	Samsung Medical Center
Ghrelin Levels in Pancreatic Cancer Patients	NCT00225745	Pancreatic Canc...	Blood draw	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for ghrelin

Every month we try and update this database with for ghrelin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ghrelin

Every month we try and update this database with for ghrelin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ghrelin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.