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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 January 2020 |
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Main ID: |
ISRCTN26185223 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomised Phase I/II Study with Ghrelin versus Placebo for patients with cancer-related Anorexia/Cachexia
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Scientific title:
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Randomised Phase I/II Study with Ghrelin versus Placebo for patients with cancer-related Anorexia/Cachexia |
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Date of first enrolment:
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01/03/2004 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN26185223 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Florian
Strasser |
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Address:
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Oncology and Palliative Medicine
Section Oncology/Haematology
Dept. Internal Medicine
Cantonal Hospital
9007
St.Gallen
Switzerland |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Exclusion criteria: Severe structural barriers in the upper gastrointestinal tract, bowel obstruction.
Age minimum:
Age maximum:
Gender:
Not Specified
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Health Condition(s) or Problem(s) studied
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Cancer-related anorexia/cachexia
Cancer
Cancer related disorders
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Intervention(s)
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Ghrelin intravenous versus placebo.
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Primary Outcome(s)
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1. Safety of parenteral Ghrelin administered in patients with advanced cancer suffering from the anorexia/cachexia syndrome
2. Qualitative and quantitative toxicities
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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SG 242/03
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Source(s) of Monetary Support
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Pilot Grant Swiss Institute for Applied Cancer REsearch; REsearch Grant OncoSuisse; Cancer League Eastern Switzerland; ALTANA Prize; Gastrotech DK
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Ethics review
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Status:
Approval date:
Contact:
Not provided at time of registration
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/09/2005 |
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URL:
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