Cancer CachexiaPhase 2NCT00919659
Parenteral Nutrition Support for Patients With Pancreatic Cancer
A Phase 2 study testing parenteral nutrition in people with Cancer Cachexia and Pancreatic Cancer, run by CONKO-Studiengruppe at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Cachexia, Pancreatic Cancer
- What is being tested?
- parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to May 2004
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological proved pancreatic cancer
- progressive cancer cachexia
- refractive to enteral supplementation
- informed consent
Who cannot join
- prefinal status
- septic disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Berlin - Charité
Berlin, State of Berlin, 13353
About this study
Official title: Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.
The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.
Read the detailed description
To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.
- Conditions
- Cancer Cachexia, Pancreatic Cancer
- Being tested
- parenteral nutrition
- Keywords
- parenteral nutrition, cancer cachexia, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parenteral nutritionDietary supplement
Also called no specific brand name
25kcal/kg bw with parenteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| parenteral nutrition | Experimental | 25kcal/kg/bw /day via parenteral support Receives: Dietary Supplement: parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional status presented by phase angle
Measured: 12 weeks
Secondary outcomes (1)
quantity of port infections, quantity of oedema, quantity of diarrhea
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJan 2002
- Primary completionJan 2004
- Study completionMay 2004
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONKO-Studiengruppe
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius AG
- Investigators
- helmut oettle, MD, Principal investigator, CONKO-Studiengruppe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919659
- Sponsor's protocol ID
- C25.0
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.
PubMed 20214798
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Nutrition Support for Patients With Pancreatic Cancer. A Phase II Study.
- ClinicalTrials.gov ID
- NCT00919659
- Acronym / sponsor ID
- C25.0
- Conditions
- Cancer Cachexia, Pancreatic Cancer
- Keywords
- parenteral nutrition, cancer cachexia, pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CONKO-StudiengruppeUniversity, hospital or other
- Collaborators
- Fresenius AG
- Study start
- Jan 2002
- Primary completion
- Jan 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 12 Jun 2009 (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 purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.
Detailed description
To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| parenteral nutrition | Experimental | Dietary Supplement: parenteral nutrition25kcal/kg/bw /day via parenteral support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histological proved pancreatic cancer
- progressive cancer cachexia
- refractive to enteral supplementation
- informed consent
Key exclusion criteria (2 listed)
- prefinal status
- septic disease
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 |
|---|---|---|
| parenteral nutritionAlso: no specific brand name25kcal/kg bw with parenteral nutrition | Dietary supplement | parenteral nutrition |
Primary outcome
nutritional status presented by phase angle
Time frame: 12 weeks
1 secondary outcome
quantity of port infections, quantity of oedema, quantity of diarrhea
Time frame: 12 weeks
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 12 Jun 2009.
- Derived from this study: PubMed 20214798Pelzer U, Arnold D, Govercin M, Stieler J, Doerken B, Riess H, Oettle H. Parenteral nutrition support for patients with pancreatic cancer. Results of a phase II study. BMC Cancer. 2010 Mar 9;10:86. doi: 10.1186/1471-2407-10-86.
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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.
helmut oettle, MD principal investigator
CONKO-Studiengruppe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing parenteral nutrition in people with Cancer Cachexia and Pancreatic Cancer, run by CONKO-Studiengruppe at 1 site in Germany.
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 4 inclusion and 2 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 12 Jun 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
nutritional status presented by phase angle (time frame: 12 weeks). 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 NCT00919659, 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 12 Jun 2009.