|
ISRCTN
|
ISRCTN26185223
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Randomised Phase I/II - Study with Ghrelin versus Placebo for patients with cancer-related Anorexia/Cachexia
|
|
Scientific title
|
|
|
Acronym
|
Ghrelin
|
|
Serial number at source
|
SG 242/03
|
|
Study hypothesis
|
Ghrelin is a safe new treatment option in patients with advanced cancer and involuntary loss of weight and appetite.
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Switzerland
|
|
Disease/condition/study domain
|
Cancer-related anorexia/cachexia
|
|
Participants - inclusion criteria
|
Patients with any type of advanced, incurable cancer, not requiring new or not being on antineoplastic treatment during the study period, with weight loss (>2% 2 months or >5% 6 months) and anorexia (VAS >3) will be eligible.
|
|
Participants - exclusion criteria
|
Severe structural barriers in the upper gastrointestinal tract, bowel obstruction.
|
|
Anticipated start date
|
01/03/2004
|
|
Anticipated end date
|
01/09/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
20
|
|
Interventions
|
Ghrelin intravenous versus placebo.
|
|
Primary outcome measure(s)
|
1. Safety of parenteral Ghrelin administered in patients with advanced cancer suffering from the anorexia/cachexia syndrome
2. Qualitative and quantitative toxicities
|
|
Secondary outcome measure(s)
|
Symptomatic effect of parenteral Ghrelin on appetite, other anorexia/cachexia related symptoms, and health-related quality-of-life (HRQOL) in patients with advanced cancer suffering from the anorexia/cachexia syndrome.
Effect of parenteral Ghrelin on nutritional intake and food preferences.
|
|
Sources of funding
|
Pilot Grant Swiss Institute for Applied Cancer REsearch; REsearch Grant OncoSuisse; Cancer League Eastern Switzerland; ALTANA Prize; Gastrotech DK
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Florian
Strasser
|
|
Address
|
Oncology and Palliative Medicine
Section Oncology/Haematology
Dept. Internal Medicine
Cantonal Hospital
|
|
City/town
|
St.Gallen
|
|
Zip/Postcode
|
9007
|
|
Country
|
Switzerland
|
|
Sponsor
|
Cantonal Hospital (Switzerland)
|
|
Address
|
Oncology/Haematology Dept
Internal Medicine
Cantonal Hospital
Rorschacherstrasse
|
|
City/town
|
St.Gallen
|
|
Zip/Postcode
|
9007
|
|
Country
|
Switzerland
|
|
Date applied
|
08/07/2005
|
|
Last edited
|
06/08/2007
|
|
Date ISRCTN assigned
|
12/09/2005
|
