Condition category
Cancer
Date applied
08/07/2005
Date assigned
12/09/2005
Last edited
06/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Florian Strasser

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SG 242/03

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cancer-related anorexia/cachexia

Intervention

Ghrelin intravenous versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Ghrelin

Primary outcome measures

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 trial start date

01/03/2004

Overall trial end date

01/09/2005

Reason abandoned

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

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

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

Trial participating centre

Oncology and Palliative Medicine
St.Gallen
9007
Switzerland

Sponsor information

Organisation

Cantonal Hospital (Switzerland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes