Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
SG 242/03
Study information
Scientific title
Randomised Phase I/II Study with Ghrelin versus Placebo for patients with cancer-related Anorexia/Cachexia
Acronym
Ghrelin
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
01/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
20
Total final enrolment
21
Participant exclusion criteria
Severe structural barriers in the upper gastrointestinal tract, bowel obstruction.
Recruitment start date
01/03/2004
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Switzerland
Study participating centre
Oncology and Palliative Medicine
St.Gallen
9007
Switzerland
Sponsor information
Organisation
Kantonsspital St. Gallen [St Gallen Cantonal Hospital]
Sponsor details
Oncology/Haematology Dept
Internal Medicine
Cantonal Hospital
Rorschacherstrasse
St.Gallen
9007
Switzerland
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Industry
Funder name
Pilot Grant Swiss Institute for Applied Cancer REsearch; REsearch Grant OncoSuisse; Cancer League Eastern Switzerland; ALTANA Prize; Gastrotech DK
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/01/2008 | 07/01/2020 | Yes | No |