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

Not Applicable

Completed

• Conditions: Cancer-related anorexia/cachexia; Cancer; Cancer related disorders

• Registration Number: ISRCTN26185223
• Lead Sponsor: Kantonsspital St. Gallen [St Gallen Cantonal Hospital]

Brief Summary

2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18182992 (added 07/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-09-01
• Study Start: 2005-09-12
• Last Update Posted: 21 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 21

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Safety of parenteral Ghrelin administered in patients with advanced cancer suffering from the anorexia/cachexia syndrome<br> 2. Qualitative and quantitative toxicities<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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.<br> Effect of parenteral Ghrelin on nutritional intake and food preferences.<br>