NeoplasmsNCT02828150
Integrative Parenteral Nutrition in Cancer Patients
A study testing Parenteral nutrition in people with Neoplasms and Parenteral Nutrition, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Parenteral Nutrition
- What is being tested?
- Parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2016to Dec 2017
- 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
- Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).
- Nutritional Risk Screening 2002 score ≥3.
- Expected duration of parenteral nutrition ≥7 days
- Availability to planned measurements
- Contraindication to enteral nutrition support
- Written informed consent
Who cannot join
- Age < 18 years
- Ongoing artificial nutrition before hospitalization
- Eastern Cooperative Oncology Group performance status >2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition
Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients.
International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients.
Recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.
- Conditions
- Neoplasms, Parenteral Nutrition
- Being tested
- Parenteral nutrition
- Medical subject headings
- Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral nutritionDietary supplement
Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements. Energy: resting energy expenditure [Harris-Benedict] multiplied by a factor of 1.5. Protein: 1.5 g/kg/day. In obese patients (BMI >30 kg/m2) support will be calculated on ideal body weight (BMI=23 kg/m2)
| Study group | Role | What they receive |
|---|---|---|
| Parenteral nutrition | Experimental | Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements Receives: Dietary Supplement: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle
Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support
Measured: 7 days
Secondary outcomes (4)
body weight
Change in body weight after 7 days of nutritional support
Measured: 7 days
body mass index
Change in body mass index after 7 days of nutritional support
Measured: 7 days
Handgrip strength
Changes in muscle strength after 7 days of nutritional support
Measured: 7 days
Number of participants with treatment-related adverse events as assessed by biochemistry
Changes in biochemistry after 7 days of nutritional support
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Riccardo Caccialanza, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Riccardo Caccialanza, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828150
- Sponsor's protocol ID
- 2015013559
- Status last verified
- Apr 2025
- First submitted
- 30 Jun 2016
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Caccialanza R, Cereda E, Klersy C, Bonardi C, Cappello S, Quarleri L, Turri A, Montagna E, Iacona I, Valentino F, Pedrazzoli P. Phase angle and handgrip strength are sensitive early markers of energy intake in hypophagic, non-surgical patients at nutritional risk, with contraindications to enteral nutrition. Nutrients. 2015 Mar 11;7(3):1828-40. doi: 10.3390/nu7031828.
PubMed 25768953
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Parenteral Nutrition in Hospitalized, Malnourished, Hypophagic Cancer Patients With Contraindication to Enteral Nutrition
- ClinicalTrials.gov ID
- NCT02828150
- Acronym / sponsor ID
- 2015013559
- Conditions
- Neoplasms, Parenteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Jul 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.
Although it is demonstrated that nutritional support can improve clinical outcomes, the literature shows that approximately 50% of cancer patients are not able to meet their estimated energy requirements. Recent clinical studies suggest that a supplementary support for parenteral nutrition (PN) could significantly help to improve the nutritional status of malnourished cancer patients.
International guidelines recommend the use of PN in malnourished, hypophagic, non-surgical cancer patients if enteral nutrition is not feasible and in patients affected by severe iatrogenic gastrointestinal complications and in whom inadequate food intake is anticipated for more than 7 days. However, there are no studies on the effects of integrative PN in hospitalized, malnourished, hypophagic, non-surgical cancer patients.
Recent studies have reported on the validity of bioelectrical impedance vector analysis in monitoring the body composition of patients receiving nutritional support. Particularly, phase angle proved to be a superior prognostic marker than other nutritional screening tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition | Experimental | Dietary Supplement: Parenteral nutritionPatients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of cancer (head-neck, lung, gastrointestinal, pancreas, biliary tract, haematology).
- Nutritional Risk Screening 2002 score ≥3.
- Expected duration of parenteral nutrition ≥7 days
- Availability to planned measurements
- Contraindication to enteral nutrition support
Key exclusion criteria (3 listed)
- Age < 18 years
- Ongoing artificial nutrition before hospitalization
- Eastern Cooperative Oncology Group performance status >2
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 nutritionPatients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements. Energy: resting energy expenditure [Harris-Benedict] multiplied by a factor of 1.5. Protein: 1.5 g/kg/day. In obese patients (BMI >30 kg/m2) support will be calculated on ideal body weight (BMI=23 kg/m2) | Dietary supplement | Parenteral nutrition |
Primary outcome
Phase angle
Time frame: 7 days
Change in phase angle (a specific body composition parameter assessed by bioelectrical impedance vector analysis) after 7 days of nutritional support
4 secondary outcomes
body weight
Time frame: 7 days
body mass index
Time frame: 7 days
Handgrip strength
Time frame: 7 days
Number of participants with treatment-related adverse events as assessed by biochemistry
Time frame: 7 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 May 2025.
- Background: PubMed 25768953Caccialanza R, Cereda E, Klersy C, Bonardi C, Cappello S, Quarleri L, Turri A, Montagna E, Iacona I, Valentino F, Pedrazzoli P. Phase angle and handgrip strength are sensitive early markers of energy intake in hypophagic, non-surgical patients at nutritional risk, with contraindications to enteral nutrition. Nutrients. 2015 Mar 11;7(3):1828-40. doi: 10.3390/nu7031828.
- Individual participant dataSharing planned: Undecided
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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.
Riccardo Caccialanza, MD principal investigator
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral nutrition in people with Neoplasms and Parenteral Nutrition, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 6 inclusion and 3 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 May 2025. 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 Italy. 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.
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?
Phase angle (time frame: 7 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 NCT02828150, 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 May 2025.