Insulin Treatment in Cancer Cachexia

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. Identifier: NCT00329615
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : August 21, 2009
Swedish Cancer Foundation
Medical Research Council
Information provided by:
Göteborg University

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

Condition or disease Intervention/treatment Phase
Cancer Cachexia Drug: Insulatard, flexpen Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 135 participants
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.
Study Start Date : January 2000
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Health related quality of life,
  2. food intake,
  3. resting energy expenditure,
  4. body composition,
  5. metabolic efficiency,
  6. spontaneous physical activity,
  7. blood and hormonal tests
  8. serum tumor markers

Secondary Outcome Measures :
  1. Survival

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

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

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 identifier (NCT number): NCT00329615

Department of Surgery, Inst of Clinical Sciences
Göteborg, Sweden, SE413 45
Sponsors and Collaborators
Göteborg University
Swedish Cancer Foundation
Medical Research Council
Principal Investigator: Kent G Lundholm, MD Department of Surgery, Göteborg University

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

Keywords provided by Göteborg University:
Cancer cachexia
Tumor host metabolism

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