Gastric CancerNCT01838109
Postoperative Oral Nutritional Supplementation After Major Gastrointestinal Surgery
A study testing oral nutritional supplement in people with Gastric Cancer and Colon Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer, Colon Cancer, Pancreatic Cancer
- What is being tested?
- oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Apr 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female who are 20 or more years old and not more than 80 years old
- Discharge from a hospital is planned within 2 weeks after major gastrointestinal surgery (except when ileostomy is performed)
- oral intake is possible at the time of discharge
- no preoperative chemotherapy or preoperative radiotherapy
- voluntarily agreed with the informed consent of this clinical trial
Who cannot join
- Intravenous or other specific nutritional treatment is needed
- BMI >25 and postoperative weight loss is not > 5% of preoperative body weight at the time of discharge
- Allergy to milk, whey, bean, salmon, or the investigational product
- Residual of cancer in the abdominal cavity postoperatively if it is cancer case
- Presence of synchronous other cancers that needs treatment.
- When investigator judged that the patient is not eligible to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.
- Conditions
- Gastric Cancer, Colon Cancer, Pancreatic Cancer, Duodenal Cancer, Biliary Cancer, Peptic Ulcer
- Being tested
- oral nutritional supplement
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Duodenal Neoplasms, Biliary Tract Neoplasms, Peptic Ulcer, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutritional supplementDietary supplement
Also called Encover
| Study group | Role | What they receive |
|---|---|---|
| ONS group | Experimental | oral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients Receives: Dietary Supplement: oral nutritional supplement |
| Control group | No intervention | no intervention total 87 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight decrease rate 8weeks after discharge compared with preoperative body weight
Measured: 8weeks after discharge
Secondary outcomes (8)
Changes in body weight before and after surgery
Measured: preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge
Change of body mass index before and after surgery
Measured: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge
changes in PG-SGA score and grade
Measured: preoperatively, and 2,4,8 weeks after discharge
serum hemoglobin
Measured: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total lymphocyte count
Measured: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total cholesterol
Measured: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total protein
Measured: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum albumin
Measured: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Hyuk-Joon Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838109
- Sponsor's protocol ID
- KSSMN-01
- Status last verified
- Sep 2013
- First submitted
- 10 Apr 2013
- Last updated
- 27 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Randomized Controlled Trial Evaluating Postoperative Oral Nutritional Supplementation for the Patients Who Received Major Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT01838109
- Acronym / sponsor ID
- KSSMN-01
- Conditions
- Gastric Cancer, Colon Cancer, Pancreatic Cancer, Duodenal Cancer, Biliary Cancer, Peptic Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 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.
Patients who underwent major gastrointestinal surgery is potentially at risk of malnutrition due to reduced oral intake, increased nutritional need, reduced gastrointestinal absorption function, and/or metabolic changes after surgery. The postoperative malnutrition is associated with low quality of life and seems to be related long-term nutritional status. This study is a multicenter, open-labeled prospective randomized clinical trial to examine the effect of postoperative oral nutritional supplements (ONS) after major gastrointestinal surgery by comparing the change of body weight and other nutritional parameters between the experiment group that is supplied with ONS and the control group without ONS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONS group | Experimental | Dietary Supplement: oral nutritional supplementoral administration of Encover 2 package for day starting at the time of discharge (200ml/package x 2, total 400Kcal/day) total 87 patients |
| Control group | No intervention | –no intervention total 87 patients |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female who are 20 or more years old and not more than 80 years old
- Discharge from a hospital is planned within 2 weeks after major gastrointestinal surgery (except when ileostomy is performed)
- oral intake is possible at the time of discharge
- no preoperative chemotherapy or preoperative radiotherapy
- voluntarily agreed with the informed consent of this clinical trial
Key exclusion criteria (6 listed)
- Intravenous or other specific nutritional treatment is needed
- BMI >25 and postoperative weight loss is not > 5% of preoperative body weight at the time of discharge
- Allergy to milk, whey, bean, salmon, or the investigational product
- Residual of cancer in the abdominal cavity postoperatively if it is cancer case
- Presence of synchronous other cancers that needs treatment.
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 |
|---|---|---|
| oral nutritional supplementAlso: Encover | Dietary supplement | ONS group |
Primary outcome
Body weight decrease rate 8weeks after discharge compared with preoperative body weight
Time frame: 8weeks after discharge
8 secondary outcomes
Changes in body weight before and after surgery
Time frame: preoperatively, at the time of discharge, and 2,4, 8 weeks after discharge
Change of body mass index before and after surgery
Time frame: preoperatively, at the time of discharge after surgery, and 8 weeks after discharge
changes in PG-SGA score and grade
Time frame: preoperatively, and 2,4,8 weeks after discharge
serum hemoglobin
Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total lymphocyte count
Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total cholesterol
Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum total protein
Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
serum albumin
Time frame: preoperatively, at the time of discharge, 2,4,8 weeks after discharge
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 27 May 2015.
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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.
Hyuk-Joon Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutritional supplement in people with Gastric Cancer and Colon Cancer, run by Seoul National University Hospital 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 5 inclusion and 6 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 27 May 2015. 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?
Body weight decrease rate 8weeks after discharge compared with preoperative body weight (time frame: 8weeks after discharge). 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 27 May 2015.