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Insulin Treatment in Cancer Cachexia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329615
First Posted: May 25, 2006
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 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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.

Resource links provided by NLM:


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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Weight loss
  • Systemic solid cancer

Exclusion Criteria:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00329615     History of Changes
Other Study ID Numbers: kl450112
First Submitted: May 23, 2006
First Posted: May 25, 2006
Last Update Posted: August 21, 2009
Last Verified: August 2009

Keywords provided by Göteborg University:
Cancer cachexia
Tumor host metabolism

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs