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
Secondary identifying numbers	SG 242/03

Submission date: 08/07/2005
Registration date: 12/09/2005
Last edited: 07/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Florian Strasser
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Ghrelin
Primary outcome measure	1. Safety of parenteral Ghrelin administered in patients with advanced cancer suffering from the anorexia/cachexia syndrome 2. Qualitative and quantitative toxicities
Secondary outcome measures	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.
Overall study start date	01/03/2004
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Locations

Countries of recruitment

Switzerland

Study participating centre

Oncology and Palliative Medicine

St.Gallen
9007
Switzerland

Sponsor information

Kantonsspital St. Gallen [St Gallen Cantonal Hospital]
Hospital/treatment centre

Oncology/Haematology Dept
Internal Medicine
Cantonal Hospital
Rorschacherstrasse
St.Gallen
9007
Switzerland

"ROR"	https://ror.org/00gpmb873

Funders

Funder type

Industry

Pilot Grant Swiss Institute for Applied Cancer REsearch; REsearch Grant OncoSuisse; Cancer League Eastern Switzerland; ALTANA Prize; Gastrotech DK

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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