Phase 3: Ghrelin - A Possible Opportunity to Improve Appetite
Sponsor
Göteborg University (Other)
Overall Status
Completed
CT.gov ID
NCT00681486
Collaborator
Swedish Cancer Foundation (Other), Medical Research Council (Other)
30
1
2
57
0.5
Study Details
Study Description
Brief Summary
The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, 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
Study Start Date
:
Oct 1, 2003
Actual Primary Completion Date
:
Jun 1, 2008
Actual Study Completion Date
:
Jul 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: A, 1 Ghrelin |
Drug: Ghrelin
High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
|
| Active Comparator: A, 2 Ghrelin. |
Drug: Ghrelin
Low dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
|
Outcome Measures
Primary Outcome Measures
- Food intake [June 2008]
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Weight loss
Exclusion Criteria:
- Diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of surgery, Sahlgrenska University Hospital | Göteborg | Sweden | 413 45 |
Sponsors and Collaborators
- Göteborg University
- Swedish Cancer Foundation
- Medical Research Council
Investigators
- Principal Investigator: Kent Lundholm, MD, prof, Göteborg University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00681486
Other Study ID Numbers:
- kl4501123
First Posted:
May 21, 2008
Last Update Posted:
Aug 21, 2009
Last Verified:
Aug 1, 2009