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

Status

Completed

Conditions

Intervention / Treatment

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

  • Sweden
      • 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

Göteborg University

Collaborators

Medical Research Council
Swedish Cancer Foundation

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.

General Publications

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.

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