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Ghrelin - A Possible Opportunity to Improve Appetite (Phase 3)

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ClinicalTrials.gov Identifier: NCT00681486
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : August 21, 2009
Sponsor:
Collaborators:
Swedish Cancer Foundation
Medical Research Council
Information provided by:
Göteborg University

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
Cancer Drug: Ghrelin 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 Type : Interventional  (Clinical Trial)
Estimated 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 : October 2003
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

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.




Primary Outcome Measures :
  1. Food intake [ Time Frame: June 2008 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight loss

Exclusion Criteria:

  • Diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681486


Locations
Sweden
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

Additional Information:
Responsible Party: Professor Kent Lundholm, University of Gothenburg
ClinicalTrials.gov Identifier: NCT00681486     History of Changes
Other Study ID Numbers: kl4501123
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by Göteborg University:
Ghrelin
Nutrition
Cancer patients
Survival