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NCT00681486 Clinical Trial

Ghrelin - A Possible Opportunity to Improve Appetite

Cancer Clinical Trial

— Phase 3  

Official title:
Ghrelin - A Possible Opportunity to Improve Appetite, Nutritional State, Metabolic Integrity and Physical Functioning in Cancer Patients With Progressive Weight Loss

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00681486
Other study ID # kl4501123
Secondary ID
Status Completed
Phase Phase 3
First received May 19, 2008
Last updated August 20, 2009
Start date October 2003
Est. completion date July 2008

Study information
Verified date August 2009
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

The study is designed to evaluate whether ghrelin treatment can improve appetite in weight losing cancer patients.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- Weight loss

Exclusion Criteria:

- Diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ghrelin
High dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.
• Ghrelin
Low dose of ghrelin given as subcutaneous injection once a day for the duration of 8 weeks.

Locations
Country Name City State
Sweden Department of surgery, Sahlgrenska University Hospital Göteborg

Sponsors (3)
Lead Sponsor Collaborator
Göteborg University Medical Research Council, Swedish Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Food intake June 2008 No
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