NCT00329615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
Last Updated

August 21, 2009

Status Verified

August 1, 2009

First QC Date

May 23, 2006

Last Update Submit

August 20, 2009

Conditions

Cancer Cachexia

Keywords

Cancer cachexiaTumor host metabolism

Outcome Measures

Primary Outcomes (8)

  • 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 (1)

  • Survival

Interventions

Insulatard, flexpenDRUG

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Weight loss
  • Systemic solid cancer

You may not qualify if:

  • Diabetes
  • Brain metastases
  • Expectant survival of less than 6 months
  • Serum creatinine above 200 umol/l
  • Persistent of recurrent fever
  • Cholestasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Inst of Clinical Sciences

Gothenburg, SE413 45, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 22727547DERIVED

MeSH Terms

Interventions

Isophane Insulin, Human

Intervention Hierarchy (Ancestors)

Insulin, IsophaneInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsInsulin, Regular, HumanInsulinProinsulinPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Kent G Lundholm, MD

    Department of Surgery, Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

January 1, 2000

Study Completion

September 1, 2005

Last Updated

August 21, 2009

Record last verified: 2009-08

Locations

SE(1)