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.
|Department of surgery, Sahlgrenska University Hospital|
|Göteborg, Sweden, 413 45|
|Principal Investigator:||Kent Lundholm, MD, prof||Göteborg University|