Pancreatic CancerPhase 3PANUSCONCT01362582
Comparing Parenteral Nutrition vs Best Supportive Nutritional Care in Patients With Pancreatic Cancer
A Phase 3 study testing SMOF Kabiven in people with Pancreatic Cancer, run by National Center for Tumor Diseases, Heidelberg at 4 sites in Germany.
Trial summary
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SMOF Kabiven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesGermany
- Study dates
- Mar 2010to Sep 2014
- Phase
- Phase 3
- 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
- Written informed consent
- Histological confirmed advanced pancreatic adenocarcinoma
- At least one previous chemotherapy (gemcitabine-based)
- ≥ 18 years old
- Body weight ≥ 50 and ≤ 95 kg
- BMI ≥ 19
Show all 9Show fewer
- Negative pregnancy test (females of childbearing potential)
- Willingness to perform double-barrier contraception during study
- Expected life expectancy > 3 months
Who cannot join
- Major surgery < 4 weeks prior to enrollment
- Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
- PINI-Index > 10
- Pregnancy or breastfeeding
- > 4 weeks of parenteral nutrition within the last 6 months
- Parenteral nutrition < 4 weeks prior to enrollment
- Vulnerable populations (e.g. subjects incapable of giving consent personally)
- Subject selection conflicts with warnings, precautions and contraindications stated for any investigational product
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Onkologische Schwerpunktpraxis und Tagesklinik
Bad Soden, 65812
Krankenhaus Nordwest Frankfurt
Frankfurt am Main, 60488
University Hospital of Heidelberg / National Center for Tumordiseases
Heidelberg, 69120
Asklepios Klinik Weißenfels
Weißenfels, 06667
About this study
Official title: Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).
Read the detailed description
Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for.
Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?
- Conditions
- Pancreatic Cancer
- Being tested
- SMOF Kabiven
- Keywords
- Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy
- 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.
SMOF KabivenDrug
SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy, Nutritional Care | No intervention | 5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Subjects in the control group receive Best Supportive Nutritional Care. BSNC is defined as nutritional consultation and recommendation by experienced ecotrophologists. |
| PN, Chemotherapy, Nutritional Care | Experimental | 5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43.
Patients receive also Best Supportive Nutritional Care defined as nutritional consultation and recommendation by experienced ecotrophologists.
Intervention: Supportive Parenteral Nutrition Receives: Drug: SMOF Kabiven |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire EORTC - Quality of Life
The following questionnaires will be given to subjects:
- EORTC QLQ-C30 (every 1st and 22nd day of a cycle)
- EORTC QLQ Pan-26 (every 1st and 22nd day of a cycle)
Measured: every 1st and 22nd day of a cycle
Secondary outcomes (1)
Assessment of nutritional status
- BIA: Phase angle, BCM and Extracellular Mass (ECM)/BCM ratio (every 1st and 22nd day of a cycle)
- BMI (every 1st and 22nd day of a cycle)
- Biceps size(every 1st and 22nd day of a cycle)
- Hand-grip-strength(every 1st and 22nd day of a cycle)
- PINI-Index (every 1st and 22nd day of a cycle)
Measured: every 1st and 22nd day of a cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study startMar 2010
- Primary completionAug 2014
- Study completionSep 2014
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 Pancreatic CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Tumor Diseases, Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Sponsor
- Investigators
- Dirk Jäger, Prof. Dr., Principal investigator, University of Heidelberg / National Center for Tumordiseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362582
- Sponsor's protocol ID
- NCT-2008-11-03-1018
- Other IDs
- 60516908
- Acronym
- PANUSCO
- Status last verified
- Sep 2014
- First submitted
- 25 Nov 2010
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marten A, Wente MN, Ose J, Buchler MW, Rotzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jager D. An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO. BMC Cancer. 2009 Nov 27;9:412. doi: 10.1186/1471-2407-9-412.
PubMed 19943918
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Multicentre Phase IIIb Trial Comparing Parenteral Substitution Versus Best Supportive Nutritional Care in Patients With Pancreatic Cancer Receiving 2nd Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01362582
- Acronym / sponsor ID
- PANUSCO / NCT-2008-11-03-1018
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, progression under chemotherapy, parenteral nutrition, pancreatic adenocarcinoma, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Center for Tumor Diseases, HeidelbergUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 May 2011 (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.
A randomised multicentre clinical phase IIIb trial for patients suffering from pancreatic adenocarcinoma receiving defined second or higher line chemotherapy and additionally parenteral nutrition (study arm A) or best supportive nutritional care (study arm B).
Detailed description
Pancreatic cancer is an extremely aggressive malignancy characterized by extensive invasion, early metastasis, and marked cachexia. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia and deterioration in performance status, even when their tumour burden is low. Therefore, one of the most important therapeutic targets is the improvement of quality of life. Supplementation with parenteral nutrition improves Quality of Life in subjects with advanced cancer cachexia. The European Society of Parenteral and Enteral Nutrition recommend PN only for malnourished subjects but does not reflect situation in cancer cachexia patients At present, no 2nd-line therapy (or higher) is recommended for pancreatic adenocarcinoma, but often asked for.
Within this clinical trial, we evaluate if parenteral nutrition in combination with chemotherapy in subjects with advanced pancreatic adenocarcinoma have an impact on quality of life?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy, Nutritional Care | No intervention | –5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Subjects in the control group receive Best Supportive Nutritional Care. BSNC is defined as nutritional consultation and recommendation by experienced ecotrophologists. |
| PN, Chemotherapy, Nutritional Care | Experimental | Drug: SMOF Kabiven5-Fluorouracil (5-FU) 2000mg/m2 IV (24-hour)/folinic acid (FA) 200mg/m2 IV (30 min) will be administered weekly over four weeks with additional oxaliplatin 85 mg/m2 IV (2-hour) on days 8 and 22. Therapy will be interrupted between days 23 to 42. The next cycle will be started on day 43. Patients receive also Best Supportive Nutritional Care defined as nutritional consultation and recommendation by experienced ecotrophologists. Intervention: Supportive Parenteral Nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent
- Histological confirmed advanced pancreatic adenocarcinoma
- At least one previous chemotherapy (gemcitabine-based)
- ≥ 18 years old
- Body weight ≥ 50 and ≤ 95 kg
Key exclusion criteria (8 listed)
- Major surgery < 4 weeks prior to enrollment
- Weight loss > 2% within the last seven days or caloric intake ≤ 500 kcal expected within the next five days
- PINI-Index > 10
- Pregnancy or breastfeeding
- > 4 weeks of parenteral nutrition within the last 6 months
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 |
|---|---|---|
| SMOF KabivenSMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml. | Drug | PN, Chemotherapy, Nutritional Care |
Primary outcome
Questionnaire EORTC - Quality of Life
Time frame: every 1st and 22nd day of a cycle
The following questionnaires will be given to subjects: * EORTC QLQ-C30 (every 1st and 22nd day of a cycle) * EORTC QLQ Pan-26 (every 1st and 22nd day of a cycle)
1 secondary outcome
Assessment of nutritional status
Time frame: every 1st and 22nd day of a cycle)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Background: PubMed 19943918Marten A, Wente MN, Ose J, Buchler MW, Rotzer I, Decker-Baumann C, Karapanagiotou-Schenkel I, Harig S, Schmidt J, Jager D. An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO. BMC Cancer. 2009 Nov 27;9:412. doi: 10.1186/1471-2407-9-412.
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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.
Dirk Jäger, Prof. Dr. principal investigator
University of Heidelberg / National Center for Tumordiseases
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SMOF Kabiven in people with Pancreatic Cancer, run by National Center for Tumor Diseases, Heidelberg at 4 sites 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Questionnaire EORTC - Quality of Life (time frame: every 1st and 22nd day of a cycle). 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 NCT01362582, 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 25 Sep 2014.