NCT00329615CompletedPhase 4
Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.
Göteborg University2 sites in 1 country135 target enrollmentStarted: January 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Health related quality of life,
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Weight loss
- •Systemic solid cancer
Exclusion Criteria
- •Brain metastases
- •Expectant survival of less than 6 months
- •Serum creatinine above 200 umol/l
- •Persistent of recurrent fever
- •Cholestasis
Outcomes
Primary Outcomes
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 Outcomes
- Survival
Investigators
Study Sites (2)
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