Pancreatic CancerNCT02626195
Preoperative Nutritional Support in Malnutritional Cancer Patients
A study testing nutritional support program in people with Pancreatic Cancer and Biliary Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Biliary Cancer, Malnutrition
- What is being tested?
- nutritional support program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to 5 Apr 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
- Patients diagnosed with malnutrition (at least more than one)
- PG-SGA B or C
- Weight loss >10% within 6 month
- BMI <18.5
- Serum Albumin <3.0
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- Age less than 80 years old over 20 years old
- Performance status (ECOG scale): 0-1
- Adequate organ functions
- Hb ≥7.0 g/dl
- ANC ≥1,500/mm3
- PLT ≥80,000/mm3
- Liver function: AST/ALT ≤5×upper limit of normal
- Creatinine ≤2.0 ULN
Who cannot join
- Biopsy, drainage tube insertion, and other minor surgery
- palliative surgery
- Serious illness or medical conditions, as follows;
- congestive heart failure (NYHA class III or IV)
- unstable angina or myocardial infarction within the past 6 months,
- significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
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- uncontrolled hypertension
- hepatic cirrhosis( ≥ Child class B)
- interstitial pneumonia, pulmonary adenomatosis
- psychiatric disorder that may interfere with and/or protocol compliance
- unstable diabetes mellitus
- uncontrolled ascites or pleural effusion
- active infection
- Pregnancy
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.
The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.
Read the detailed description
This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).
For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
- Calories: 30-35Kg, via enteral or parenteral
- Protein: 1.2-1.5g/Kg
- Lipid : 1-1.5g/Kg
- Mineral and vitamins supply
- Blood glucose control
- Daily monitoring by dietician and specialized nurse
- Conditions
- Pancreatic Cancer, Biliary Cancer, Malnutrition
- Being tested
- nutritional support program
- Keywords
- malnutrition, nutrition, nutritional support, hepatobiliary pancreatic cancer, hepatobiliary pancreatic surgery
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional support programDietary supplement
Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
- Calories: 30-35Kg, via enteral or parenteral
- Protein: 1.2-1.5g/Kg
- Lipid : 1-1.5g/Kg
- Mineral and vitamins supply
- Blood glucose control
- Daily monitoring by dietician and specialized nurse
| Study group | Role | What they receive |
|---|---|---|
| nutritional support program apply | Experimental | Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program. Receives: Dietary Supplement: nutritional support program |
| historical control group | No intervention | Historical control group is that did not receiving |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complication
expected the duration of hospital stay of postoperation is 4~6 weeks.
Measured: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
Secondary outcomes (3)
postoperative hospital stay
expected the duration of hospital stay of postoperation is 4~6 weeks.
Measured: expected the duration of hospital stay of postoperation is 4~6 weeks.
quality of life
preoperative, postoperative 14days
Measured: preoperative, postoperative 14days
postoperative cost( + nutritional support cost)
expected the duration of hospital stay of postoperation is 4~6 weeks.
Measured: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startOct 2013
- Primary completion27 Nov 2013
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Sang-Jae Park, National Cancer Center, Korea
- Investigators
- SangJae Park, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626195
- Sponsor's protocol ID
- NCCCTS-13-676
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2015
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients
- ClinicalTrials.gov ID
- NCT02626195
- Acronym / sponsor ID
- NCCCTS-13-676
- Conditions
- Pancreatic Cancer, Biliary Cancer, Malnutrition
- Keywords
- malnutrition, nutrition, nutritional support, hepatobiliary pancreatic cancer, hepatobiliary pancreatic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Fresenius Kabi
- Study start
- Oct 2013
- Primary completion
- 27 Nov 2013 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 10 Dec 2015 (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.
Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.
The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.
Detailed description
This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).
For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.
Interval: 5-10 days Contents: admission is required
- Calories: 30-35Kg, via enteral or parenteral
- Protein: 1.2-1.5g/Kg
- Lipid : 1-1.5g/Kg
- Mineral and vitamins supply
- Blood glucose control
- Daily monitoring by dietician and specialized nurse
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutritional support program apply | Experimental | Dietary Supplement: nutritional support programPreoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program. |
| historical control group | No intervention | –Historical control group is that did not receiving |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
- Patients diagnosed with malnutrition (at least more than one)
- Age less than 80 years old over 20 years old
- Performance status (ECOG scale): 0-1
- Adequate organ functions
Key exclusion criteria (15 listed)
- Biopsy, drainage tube insertion, and other minor surgery
- palliative surgery
- Serious illness or medical conditions, as follows;
- Pregnancy
- Any patients judged by the investigator to be unfit to participate in the study
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 |
|---|---|---|
| nutritional support programNutritional support program is briefly described below. Interval: 5-10 days Contents: admission is required * Calories: 30-35Kg, via enteral or parenteral * Protein: 1.2-1.5g/Kg * Lipid : 1-1.5g/Kg * Mineral and vitamins supply * Blood glucose control * Daily monitoring by dietician and specialized nurse | Dietary supplement | nutritional support program apply |
Primary outcome
postoperative complication
Time frame: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
expected the duration of hospital stay of postoperation is 4~6 weeks.
3 secondary outcomes
postoperative hospital stay
Time frame: expected the duration of hospital stay of postoperation is 4~6 weeks.
quality of life
Time frame: preoperative, postoperative 14days
postoperative cost( + nutritional support cost)
Time frame: at discharge. (expected the duration of hospital stay of postoperation is 4~6 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 11 Jun 2018.
- 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.
SangJae Park principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional support program in people with Pancreatic Cancer and Biliary Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 14 inclusion and 15 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 11 Jun 2018. 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 South Korea. 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?
postoperative complication (time frame: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2018.