Insulin Treatment in Cancer Cachexia
August 20, 2009 updated by: Göteborg University
Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.
The study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.
Study Overview
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
Enrollment
135
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Göteborg, Sweden, SE413 45
- Department of Surgery, Inst of Clinical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
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
Outcome Measure |
|---|
|
Survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kent G Lundholm, MD, Department of Surgery, Göteborg University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
May 23, 2006
First Submitted That Met QC Criteria
May 23, 2006
First Posted (Estimate)
May 25, 2006
Study Record Updates
Last Update Posted (Estimate)
August 21, 2009
Last Update Submitted That Met QC Criteria
August 20, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- kl450112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.