Weight LossNUPANNCT02670265
Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions
A study testing Olimel Peri 2.5% ® and Isotonic fluid (E153) in people with Weight Loss and Pancreatic Cancer, run by University Medicine Greifswald.
Trial summary
Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. In a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Pancreatic Cancer, Biliary Tract Cancer
- What is being tested?
- Olimel Peri 2.5% ® and Isotonic fluid (E153)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Feb 2014
- Phase
- Interventional
- 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
- Hospitalization for suspected biliopancreatic mass lesion
- Consent to participate to the study
Who cannot join
- Liver cirrhosis (Child-Pugh B and C)
- Heart or renal failure (grade III or more)
- Dementia
- Pregnancy
- Hospital stay less than 3 days
About this study
Official title: Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. In a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and length of hospital stay.
Read the detailed description
Patients with pancreatic and biliary tract cancer suffer from weight loss, malnutrition and cachexia. These factors are associated with poor prognosis, reduction in quality of life and a higher risk of complications during treatment. Moreover, patients undergo fasting periods during their diagnostic work-up at hospital that worsens malnutrition.
This is a prospective randomized monocentric study to investigate, whether parenteral nutritional supplementation may have an impact on weight loss, nutritional status, quality of life and length of hospital stay in patients with tumors of the pancreas or biliary tract. Patients either receive 1 l Olimel peri 2.5 %® (Baxter Germany GmbH Medication Delivery, Unterschleißheim, Germany containing 700 kcal, 25.3 g protein, 30.0 g fat and 75.0 g glucose) on fasting days or 1 l of isotonic fluid (E153, Berlin-Chemie AG, Berlin, Germany) in the control group. A hospital stay of at least three days is required. Patients are assessed for anthropometric measurements, bioelectrical impedance analysis, quality of life and length of hospital stay.
- Conditions
- Weight Loss, Pancreatic Cancer, Biliary Tract Cancer
- Being tested
- Olimel Peri 2.5% ®, Isotonic fluid (E153)
- Keywords
- malnutrition, parenteral nutrition, weight loss, pancreatic cancer, biliary tract cancer, quality of life
- Medical subject headings
- Weight Loss, Pancreatic Neoplasms, Biliary Tract Neoplasms, Malnutrition, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olimel Peri 2.5% ®Dietary supplement
During hospital stay patients received 1 l Olimel peri 2.5 %® containing 700 kcal (25.3 g protein, 30.0 g fat and 75.0 g glucose) daily by intravenous route.
Isotonic fluid (E153)Dietary supplement
Controls received 1l of isotonic fluid daily by intravenous route.
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition | Active comparator | Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany) Receives: Dietary Supplement: Olimel Peri 2.5% ® |
| Isotonic fluid | Placebo comparator | Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany) Receives: Dietary Supplement: Isotonic fluid (E153) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Influence of Olimel Peri 2.%% ® on body weight
Measured: ≥ 3 days
Secondary outcomes (3)
Nutritional status
Bioelectrical analysis (BIA) was performed. BCM/ECM index, phase angle, body fat were measured.
Measured: ≥ 3 days
Quality of life
Quality of life was determined using the European EORTC QLQ-C30 form.
Measured: ≥ 3 days
Length of hospital stay
Length of hospital stay was calculated in days.
Measured: ≥ 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 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 Weight LossStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus M Lerch, MD, Principal investigator, Department of Medicine A, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670265
- Sponsor's protocol ID
- BB61/12
- Acronym
- NUPAN
- Status last verified
- Jan 2016
- First submitted
- 28 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kruger J, Meffert PJ, Vogt LJ, Gartner S, Steveling A, Kraft M, Mayerle J, Lerch MM, Aghdassi AA. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial. PLoS One. 2016 Nov 18;11(11):e0166513. doi: 10.1371/journal.pone.0166513. eCollection 2016.
PubMed 27861546
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions (NUPAN), a Prospective Randomized Interventional Trial
- ClinicalTrials.gov ID
- NCT02670265
- Acronym / sponsor ID
- NUPAN / BB61/12
- Conditions
- Weight Loss, Pancreatic Cancer, Biliary Tract Cancer
- Keywords
- malnutrition, parenteral nutrition, weight loss, pancreatic cancer, biliary tract cancer, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Feb 2016 (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.
Patients with biliopancreatic tumors are at risk for malnutrition and have to undergo many procedures for diagnostic workup that require fasting periods. In a prospective randomized monocentric study we evaluate the effect of additional parenteral nutrition on weight loss, nutritional status, quality of life and length of hospital stay.
Detailed description
Patients with pancreatic and biliary tract cancer suffer from weight loss, malnutrition and cachexia. These factors are associated with poor prognosis, reduction in quality of life and a higher risk of complications during treatment. Moreover, patients undergo fasting periods during their diagnostic work-up at hospital that worsens malnutrition.
This is a prospective randomized monocentric study to investigate, whether parenteral nutritional supplementation may have an impact on weight loss, nutritional status, quality of life and length of hospital stay in patients with tumors of the pancreas or biliary tract. Patients either receive 1 l Olimel peri 2.5 %® (Baxter Germany GmbH Medication Delivery, Unterschleißheim, Germany containing 700 kcal, 25.3 g protein, 30.0 g fat and 75.0 g glucose) on fasting days or 1 l of isotonic fluid (E153, Berlin-Chemie AG, Berlin, Germany) in the control group. A hospital stay of at least three days is required. Patients are assessed for anthropometric measurements, bioelectrical impedance analysis, quality of life and length of hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | Active comparator | Dietary Supplement: Olimel Peri 2.5% ®Active Comparator: Olimel peri 2.5% ® 1l/d (700 kcal/d) (Baxter GmbH, Unterschleißheim, Germany) |
| Isotonic fluid | Placebo comparator | Dietary Supplement: Isotonic fluid (E153)Isotonic fluid 1l/d (E153, Berlin-Chemie AG, Berlin, Germany) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalization for suspected biliopancreatic mass lesion
- Consent to participate to the study
Key exclusion criteria (5 listed)
- Liver cirrhosis (Child-Pugh B and C)
- Heart or renal failure (grade III or more)
- Dementia
- Pregnancy
- Hospital stay less than 3 days
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 |
|---|---|---|
| Olimel Peri 2.5% ®During hospital stay patients received 1 l Olimel peri 2.5 %® containing 700 kcal (25.3 g protein, 30.0 g fat and 75.0 g glucose) daily by intravenous route. | Dietary supplement | Parenteral nutrition |
| Isotonic fluid (E153)Controls received 1l of isotonic fluid daily by intravenous route. | Dietary supplement | Isotonic fluid |
Primary outcome
Weight loss
Time frame: ≥ 3 days
Influence of Olimel Peri 2.%% ® on body weight
3 secondary outcomes
Nutritional status
Time frame: ≥ 3 days
Quality of life
Time frame: ≥ 3 days
Length of hospital stay
Time frame: ≥ 3 days
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 1 Feb 2016.
- Derived from this study: PubMed 27861546Kruger J, Meffert PJ, Vogt LJ, Gartner S, Steveling A, Kraft M, Mayerle J, Lerch MM, Aghdassi AA. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial. PLoS One. 2016 Nov 18;11(11):e0166513. doi: 10.1371/journal.pone.0166513. eCollection 2016.
- Individual participant dataSharing planned: No
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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.
Markus M Lerch, MD principal investigator
Department of Medicine A, University Medicine Greifswald
Questions about this trial
What is this clinical trial studying?
A study testing Olimel Peri 2.5% ® and Isotonic fluid (E153) in people with Weight Loss and Pancreatic Cancer, run by University Medicine Greifswald.
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 5 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Weight loss (time frame: ≥ 3 days). 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 NCT02670265, 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 1 Feb 2016.