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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681486
First Posted: May 21, 2008
Last Update Posted: August 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Swedish Cancer Foundation
Medical Research Council
Information provided by:
Göteborg University
  Purpose
The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

Condition Intervention Phase
Cancer Drug: Ghrelin Phase 3

Study Type: Interventional
Study Design: 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

Further study details as provided by Göteborg University:

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

Estimated Enrollment: 30
Study Start Date: October 2003
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Weight loss

Exclusion Criteria:

  • Diabetes
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Professor Kent Lundholm, University of Gothenburg
ClinicalTrials.gov Identifier: NCT00681486     History of Changes
Other Study ID Numbers: kl4501123
First Submitted: May 19, 2008
First Posted: May 21, 2008
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by Göteborg University:
Ghrelin
Nutrition
Cancer patients
Survival