Insulin Treatment in Cancer Cachexia

Cancer Cachexia Clinical Trial

Official title:

Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329615
• Other study ID #: kl450112
• Status: Completed
• Phase: Phase 4
• First received: May 23, 2006
• Last updated: August 20, 2009
• Start date: January 2000
• Est. completion date: September 2005

Study information

• Verified date: August 2009
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Drug:
• Insulatard, flexpen

Locations

Country	Name	City	State
Sweden	Department of Surgery, Inst of Clinical Sciences	Göteborg

Sponsors (3)

Lead Sponsor	Collaborator
Göteborg University	Medical Research Council, Swedish Cancer Foundation

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related quality of life,
Primary	food intake,
Primary	resting energy expenditure,
Primary	body composition,
Primary	metabolic efficiency,
Primary	spontaneous physical activity,
Primary	blood and hormonal tests
Primary	serum tumor markers
Secondary	Survival