Ghrelin - A Possible Opportunity to Improve Appetite (Phase 3)
The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Ghrelin - A Possible Opportunity to Improve Appetite, Nutritional State, Metabolic Integrity and Physical Functioning in Cancer Patients With Progressive Weight Loss|
- Food intake [ Time Frame: June 2008 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Active Comparator: A, 1
High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
Active Comparator: A, 2
Low dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
Randomized study with follow up evaluations each month until preterminal state. Cancer patients will be randomised to either high dose or low dose of active treatment given as daily injection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681486
|Department of surgery, Sahlgrenska University Hospital|
|Göteborg, Sweden, 413 45|
|Principal Investigator:||Kent Lundholm, MD, prof||Göteborg University|