Randomised Phase I/II Study with Ghrelin versus Placebo for patients with cancer-related Anorexia/Cachexia

ISRCTN	ISRCTN26185223
DOI	https://doi.org/10.1186/ISRCTN26185223
Protocol serial number	SG 242/03
Sponsor	Kantonsspital St. Gallen [St Gallen Cantonal Hospital]
Funder	Pilot Grant Swiss Institute for Applied Cancer REsearch; REsearch Grant OncoSuisse; Cancer League Eastern Switzerland; ALTANA Prize; Gastrotech DK

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Florian Strasser
Scientific

Oncology and Palliative Medicine
Section Oncology/Haematology
Dept. Internal Medicine
Cantonal Hospital
St.Gallen
9007
Switzerland

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Randomised Phase I/II Study with Ghrelin versus Placebo for patients with cancer-related Anorexia/Cachexia
Study acronym	Ghrelin
Study objectives	Ghrelin is a safe new treatment option in patients with advanced cancer and involuntary loss of weight and appetite.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer-related anorexia/cachexia
Intervention	Ghrelin intravenous versus placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ghrelin
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
Key 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.
Completion date	01/09/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	20
Total final enrolment	21
Key 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.
Key exclusion criteria	Severe structural barriers in the upper gastrointestinal tract, bowel obstruction.
Date of first enrolment	01/03/2004
Date of final enrolment	01/09/2005

Oncology and Palliative Medicine

St.Gallen
9007
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/01/2008	07/01/2020	Yes	No

07/01/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.