Cancer CachexiaPhase 4NCT00329615
Insulin Treatment in Cancer Cachexia
A Phase 4 study testing Insulatard, flexpen in people with Cancer Cachexia, run by Göteborg University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Cancer Cachexia
- What is being tested?
- Insulatard, flexpen
- How many people
- 135 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2000to Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight loss
- Systemic solid cancer
Who cannot join
- Diabetes
- Brain metastases
- Expectant survival of less than 6 months
- Serum creatinine above 200 umol/l
- Persistent of recurrent fever
- Cholestasis
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery, Inst of Clinical Sciences
Gothenburg, SE413 45
About this study
Official title: Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.
The study is designed to evaluate whether daily insulin treatment to weight losing cancer patients attenuates progression of cancer cachexia and improves metabolism.
Read the 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.
- Conditions
- Cancer Cachexia
- Being tested
- Insulatard, flexpen
- Keywords
- Cancer cachexia, Tumor host metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulatard, flexpenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startJan 2000
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer CachexiaStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Foundation, Medical Research Council
- Investigators
- Kent G Lundholm, MD, Principal investigator, Department of Surgery, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329615
- Sponsor's protocol ID
- kl450112
- Status last verified
- Aug 2009
- First submitted
- 23 May 2006
- Last updated
- 21 Aug 2009
- Results posted
- No
Publications
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.
PubMed 22727547
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Treatment in Cancer Cachexia: Effects on Survival, Metabolism and Physical Functioning. A Randomized Prospective Study.
- ClinicalTrials.gov ID
- NCT00329615
- Acronym / sponsor ID
- kl450112
- Conditions
- Cancer Cachexia
- Keywords
- Cancer cachexia, Tumor host metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Swedish Cancer Foundation, Medical Research Council
- Study start
- Jan 2000
- Study completion
- Sep 2005 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Weight loss
- Systemic solid cancer
Key exclusion criteria (6 listed)
- Diabetes
- Brain metastases
- Expectant survival of less than 6 months
- Serum creatinine above 200 umol/l
- Persistent of recurrent fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulatard, flexpen | Drug | – |
Primary outcome
Health related quality of life,
food intake,
resting energy expenditure,
body composition,
metabolic efficiency,
spontaneous physical activity,
blood and hormonal tests
serum tumor markers
1 secondary outcome
Survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2009.
- Derived from this study: PubMed 22727547Wallengren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kent G Lundholm, MD principal investigator
Department of Surgery, Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulatard, flexpen in people with Cancer Cachexia, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life,. The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2009.