Insulin Treatment in Cancer Cachexia

NCT ID: NCT00329615

Last Updated: 2009-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Cancer Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Insulatard, flexpen

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Cancer Foundation

OTHER

Sponsor Role collaborator

Medical Research Council

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Principal Investigators

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Kent G Lundholm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Göteborg University

Locations

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Department of Surgery, Inst of Clinical Sciences

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 22727547 (View on PubMed)

Other Identifiers

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kl450112

Identifier Type: -

Identifier Source: org_study_id

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