MalnutritionEarly Phase 1NCT01830907
Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002
A Early Phase 1 study testing carbohydrates and vitamins in people with Malnutrition and Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malnutrition, Gastric Cancer
- What is being tested?
- carbohydrates and vitamins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Mar 2013
- Phase
- Early Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of gastric cancer surgery preoperative stage
Who cannot join
- neoadjuvent chemoradiation
- pregnant
- advanced stage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial
Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.
- Conditions
- Malnutrition, Gastric Cancer
- Being tested
- carbohydrates, vitamins
- Keywords
- Malnutrition, Gastric cancer, preoperative nutrition
- Medical subject headings
- Malnutrition, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydratesDietary supplement
vitaminsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Enteral | Active comparator | Enteral nutrition composed of carbohydrates and vitamins Receives: Dietary Supplement: carbohydrates; Dietary Supplement: vitamins |
| Parenteral | Active comparator | Not described Receives: Dietary Supplement: carbohydrates; Dietary Supplement: vitamins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious complication
Measured: 30 days
Secondary outcomes (1)
Length of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionMar 2013
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 MalnutritionStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Punyaram Kharbuja, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830907
- Sponsor's protocol ID
- First Hospital of JLU
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van Stijn MF, Korkic-Halilovic I, Bakker MS, van der Ploeg T, van Leeuwen PA, Houdijk AP. Preoperative nutrition status and postoperative outcome in elderly general surgery patients: a systematic review. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):37-43. doi: 10.1177/0148607112445900. Epub 2012 May 1.
PubMed 22549764
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Nutritional Support on Postoperative Outcome in Gastric Cancer Patients at Nutritional Risk by NRS-2002- A Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01830907
- Acronym / sponsor ID
- First Hospital of JLU
- Conditions
- Malnutrition, Gastric Cancer
- Keywords
- Malnutrition, Gastric cancer, preoperative nutrition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Apr 2013 (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.
Evaluation of the impact of preoperative nutritional support on clinical outcomes in patients at nutritional risk. The primary endpoint was the complication rate and the second endpoint was the length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteral | Active comparator | Dietary Supplement: carbohydrates, Dietary Supplement: vitaminsEnteral nutrition composed of carbohydrates and vitamins |
| Parenteral | Active comparator | Dietary Supplement: carbohydrates, Dietary Supplement: vitamins |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of gastric cancer surgery preoperative stage
Key exclusion criteria (3 listed)
- neoadjuvent chemoradiation
- pregnant
- advanced stage
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 |
|---|---|---|
| carbohydrates | Dietary supplement | Enteral, Parenteral |
| vitamins | Dietary supplement | Enteral, Parenteral |
Primary outcome
Infectious complication
Time frame: 30 days
1 secondary outcome
Length of hospital stay
Time frame: 30 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 12 Apr 2013.
- Background: PubMed 22549764van Stijn MF, Korkic-Halilovic I, Bakker MS, van der Ploeg T, van Leeuwen PA, Houdijk AP. Preoperative nutrition status and postoperative outcome in elderly general surgery patients: a systematic review. JPEN J Parenter Enteral Nutr. 2013 Jan;37(1):37-43. doi: 10.1177/0148607112445900. Epub 2012 May 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing carbohydrates and vitamins in people with Malnutrition and Gastric Cancer, run by The First Hospital of Jilin University at 1 site in China.
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 1 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 12 Apr 2013. 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Infectious complication (time frame: 30 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 NCT01830907, 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 Apr 2013.