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

Tracking Information

First Received Date ^ICMJE

May 19, 2008

Last Updated Date

August 20, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Food intake [ Time Frame: June 2008 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00681486 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ghrelin - A Possible Opportunity to Improve Appetite

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: A, 1
Ghrelin

Intervention: Drug: Ghrelin
Active Comparator: A, 2
Ghrelin.

Intervention: Drug: Ghrelin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Weight loss

Exclusion Criteria:

Diabetes

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00681486

Other Study ID Numbers ^ICMJE

kl4501123

Has Data Monitoring Committee

Not Provided

Responsible Party

Professor Kent Lundholm, University of Gothenburg

Study Sponsor ^ICMJE

Göteborg University

Collaborators ^ICMJE

Swedish Cancer Foundation
Medical Research Council

Investigators ^ICMJE

Principal Investigator:

Kent Lundholm, MD, prof

Göteborg University

Information Provided By

Göteborg University

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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