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

This study has been completed.
Sponsor:
Collaborators:
Swedish Cancer Foundation
Medical Research Council
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00681486
First received: May 19, 2008
Last updated: August 20, 2009
Last verified: August 2009
History of Changes
  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
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Food intake [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight loss

Exclusion Criteria:

  • Diabetes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Göteborg University  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Professor Kent Lundholm, University of Gothenburg
ClinicalTrials.gov Identifier: NCT00681486     History of Changes
Other Study ID Numbers: kl4501123
Study First Received: May 19, 2008
Last Updated: August 20, 2009
Health Authority: Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare

Keywords provided by Göteborg University:
Ghrelin
Nutrition
Cancer patients
Survival

ClinicalTrials.gov processed this record on May 23, 2013