Insulin Treatment in Cancer Cachexia - Full Text View

Sponsors and Collaborators:	Göteborg University Swedish Cancer Foundation Medical Research Council
Information provided by:	Göteborg University
ClinicalTrials.gov Identifier:	NCT00329615

Purpose

The study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.

Condition	Intervention	Phase
Cancer Cachexia	Drug: Insulatard, flexpen	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.

Further study details as provided by Göteborg University:

Primary Outcome Measures:

Health related quality of life,
food intake,
resting energy expenditure,
body composition,
metabolic efficiency,
spontaneous physical activity,
blood and hormonal tests
serum tumor markers

Secondary Outcome Measures:

Survival

Estimated Enrollment:	135
Study Start Date:	January 2000
Estimated Study Completion Date:	September 2005

Detailed Description:

Randomized study with long-term follow-up based on survival, health related quality of life, food intake, resting energy expenditure, body composition, exercise capacity and measurement of metabolic efficiency.

Eligibility

Ages Eligible for Study:	25 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Weight loss
Systemic solid cancer

Exclusion Criteria:

Diabetes
Brain metastases
Expectal survival of less than 6 months
Serum creatinine above 200 umol/l
Persistent of recurrent fever
Cholestasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329615

Locations

Sweden
Department of Surgery, Inst of Clinical Sciences
Göteborg, Sweden, SE413 45

Sponsors and Collaborators

Göteborg University

Swedish Cancer Foundation

Medical Research Council

Investigators

Principal Investigator:

Kent G Lundholm, MD

Department of Surgery, Göteborg University

More Information

Study ID Numbers:	kl450112
Study First Received:	May 23, 2006
Last Updated:	May 23, 2006
ClinicalTrials.gov Identifier:	NCT00329615
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Göteborg University:

Cancer cachexia
Tumor host metabolism

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes

Cachexia
Emaciation
Insulin

ClinicalTrials.gov processed this record on January 15, 2009