Text Size

Insulin Treatment in Cancer Cachexia

This study has been completed.
Sponsor:
Collaborators:
Swedish Cancer Foundation
Medical Research Council
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00329615
First received: May 23, 2006
Last updated: August 20, 2009
Last verified: August 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

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
  • Expectant 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

No publications provided

ClinicalTrials.gov Identifier: NCT00329615     History of Changes
Other Study ID Numbers: kl450112
Study First Received: May 23, 2006
Last Updated: August 20, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Göteborg University:
Cancer cachexia
Tumor host metabolism

Additional relevant MeSH terms:
Cachexia
Emaciation
Weight Loss
 Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013