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Insulin Treatment in Cancer Cachexia

Primary Purpose

Cancer Cachexia

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Insulatard, flexpen

About this trial

This is an interventional treatment trial for Cancer Cachexia focused on measuring Cancer cachexia, Tumor host metabolism

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Surgery, Inst of Clinical Sciences

Outcomes

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

Full Information

NCT ID

NCT00329615

First Posted

May 23, 2006

Last Updated

August 20, 2009

Sponsor

Göteborg University

Collaborators

Swedish Cancer Foundation, Medical Research Council

1. Study Identification

Unique Protocol Identification Number

NCT00329615

Brief Title

Insulin Treatment in Cancer Cachexia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Göteborg University

Collaborators

Swedish Cancer Foundation, Medical Research Council

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Cachexia

Keywords

Cancer cachexia, Tumor host metabolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

135 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Insulatard, flexpen

Primary Outcome Measure Information:

Title

Health related quality of life,

Title

food intake,

Title

resting energy expenditure,

Title

body composition,

Title

metabolic efficiency,

Title

spontaneous physical activity,

Title

blood and hormonal tests

Title

serum tumor markers

Secondary Outcome Measure Information:

Title

Survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kent G Lundholm, MD

Organizational Affiliation

Department of Surgery, Göteborg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Surgery, Inst of Clinical Sciences

City

Göteborg

ZIP/Postal Code

SE413 45

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

22727547

Citation

Wallengren O, Bosaeus I, Lundholm K. Dietary energy density, inflammation and energy balance in palliative care cancer patients. Clin Nutr. 2013 Feb;32(1):88-92. doi: 10.1016/j.clnu.2012.05.023. Epub 2012 Jun 23.

Results Reference

derived

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Insulin Treatment in Cancer Cachexia

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