Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00933361
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2009-07-06
Brief Title:
Individual Dose-escalated Bi-daily Subcutaneously sc Ghrelin in Cancer Cachexia a Phase III Study
Sponsor:
Cantonal Hospital of St Gallen
Organization:
Cantonal Hospital of St Gallen
Study Overview
Official Title:
Individual Dose-escalated Bi-daily sc Ghrelin in Cancer Cachexia a Phase III Study
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cachexia a condition of severe malnutrition negative nitrogen balance muscle wasting weight loss and anorexia is a frequent affecting more than 80 of patients in advanced cancer disease causing a high burden on patients and their families Nutritional pharmacological and behavioural interventions for cancer-related ACS and associated symptoms have despite the importance for cancer care limited effect on only a minority of patients New strategies are required
Ghrelin a 28 amino acid peptide discovered in 1999 is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue GHS receptor When administered peripherally it stimulates growth hormone secretion food intake triggers a positive energy balance produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects A recently completed trial on intravenous ghrelin in advanced cancer patients with ACS reports good tolerability and safety of single intravenous application of 2 and 8μgkg Ghrelin
Given the facts that ACS is a major burden in patients suffering advanced cancer disease and ghrelin is a major signal for stimulating food intake promoting positive energy balance and weight gain and may have anti-inflammatory effect it remains to be determined whether the administration of ghrelin will have a positive clinical effect on cancer anorexia cachexia syndrome ACS The next logical clinical development step is a proper dose-finding study of twice daily subcutaneous administration and proof-of-concept of main outcomes
Ghrelin a 28 amino acid peptide discovered in 1999 is predominantly secreted by gastric endocrine cells and is an endogenous ligand for the growth hormone secretagogue GHS receptor When administered peripherally it stimulates growth hormone secretion food intake triggers a positive energy balance produces weight gain through a central mechanism involving hypothalamic neuropeptides and has anti-inflammatory effects A recently completed trial on intravenous ghrelin in advanced cancer patients with ACS reports good tolerability and safety of single intravenous application of 2 and 8μgkg Ghrelin
Given the facts that ACS is a major burden in patients suffering advanced cancer disease and ghrelin is a major signal for stimulating food intake promoting positive energy balance and weight gain and may have anti-inflammatory effect it remains to be determined whether the administration of ghrelin will have a positive clinical effect on cancer anorexia cachexia syndrome ACS The next logical clinical development step is a proper dose-finding study of twice daily subcutaneous administration and proof-of-concept of main outcomes
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None