Gastric CancerNCT03123432
Immunomodulating Nutrients in Perioperative Patients With Gastric Cancer
A study testing immunomodulating nutrients enriched diet and standard diet in people with Gastric Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- immunomodulating nutrients enriched diet and standard diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2011to 1 Sep 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-85 years old
- Histologically proven primary gastric cancer or GIST.
- Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.
- Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.
Who cannot join
- They were less than 20 years or over 85 years old
- Hepatic dysfunction or bile stasis (serum total bilirubin >2.5 mg/dL)
- Renal dysfunction (serum creatinine >1.5 mg/dL), or required hemodialysis
- Cardiac dysfunction (NYHA functional class >III, or stroke history)
- Severe hypoalbuminemia (albumin <2.5 g/dL)
- Karnofsky performance status less than 60
Show all 15Show fewer
- Overweight (body mass index [BMI] >30 kg/m2)
- Exhibited drug abuse or chronic alcoholism
- Had life-threatening disease, or underwent emergent surgery
- With infection or bowel obstruction
- Pregnant or lactating
- Had received chemotherapy within 14 days of the initiation of the trial
- Had received immunosuppressive therapy or had immunological diseases recently
- Had already participated in another clinical study with an investigational drug or an investigational medical device within a month of the initiation or during the study
- Hypersensitive to casein, fish oil, soybean, or corn oil
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Kaohsiung City, 807
About this study
Official title: Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
Read the detailed description
Primary Objective:
- The primary end points: To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).
- Secondary Objectives: (1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count. (2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.
Plan of the Study:
- This is a randomized, comparative, double blinded study in 2 arms.
- Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
- Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
- Conditions
- Gastric Cancer
- Being tested
- immunomodulating nutrients enriched diet, standard diet
- Keywords
- immunomodulating nutrients
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunomodulating nutrients enriched dietDietary supplement
Also called neo-mune
standard dietDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| immunomodulating nutrients enriched diet | Experimental | Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. Receives: Dietary Supplement: immunomodulating nutrients enriched diet |
| standard diet | Active comparator | Patients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. Receives: Dietary Supplement: standard diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
immunomodulating effects
Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
Secondary outcomes (16)
blood glucose
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood urine nitrogen
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood aspartate aminotransferase (AST) in U/L
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood alanine aminotransferase (ALT) in U/L
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood triglycerides (TG) in mg/dL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood cholesterol in mg/mL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood low-density lipoprotein (LDL) in mg/mL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood high-density lipoprotein (HDL) in mg/mL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood sodium (Na) mEq/L
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood leukocyte count cells/μL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood albumin in g/dL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood prealbumin in mg/dL
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
body mass index (BMI) in kg/m^2
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
postoperative complications
postoperative complications that related to surgery
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
time to first bowel action
interval of surgery to first bowel action (hours)
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
length of hospital stay after surgery
length of hospital stay after surgery (days)
Measured: at discharge from the hospital or 14 days after surgery, whichever occurred first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jun 2011
- Primary completion1 Jun 2016
- Study completion1 Sep 2016
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 Kaohsiung Medical University Chung-Ho Memorial 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaw-Yuan Wang, MD, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Jaw-Yuan Wang, PhD, Study chair, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123432
- Sponsor's protocol ID
- KMUHIRB-2011-05-01(II)
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Arginine, Glutamine, and Omega-3 Fatty Acid Supplements for Perioperative Enteral Nutrition in Surgical Patients With Gastric Adenocarcinoma or Gastrointestinal Stromal Tumor (GIST)
- ClinicalTrials.gov ID
- NCT03123432
- Acronym / sponsor ID
- KMUHIRB-2011-05-01(II)
- Conditions
- Gastric Cancer
- Keywords
- immunomodulating nutrients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 21 Apr 2017 (actual)
- 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.
The survey is a phase IV, prospective randomized clinical trial to determine whether an immunomodulating nutrient-enriched diet compared to a standard diet can improve nutritional status and reduce postoperative infection and surgery-induced immune suppression in patients with gastric cancer or GIST undergoing major surgery in a single medical center.
Detailed description
Primary Objective:
- The primary end points: To evaluate the effect of immunomodulating diets on the postoperative inflammatory response: including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α).
- Secondary Objectives: (1). Biochemistry parameters: glucose,blood urine nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein, sodium, and leukocyte count. (2). Nutritional status: albumin, prealbumin, BMI (3). Adverse events (4). Clinical outcomes: postoperative complications, time to first bowel action and length of hospital stay after surgery.
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach 15 patients at least in each.
Plan of the Study:
- This is a randomized, comparative, double blinded study in 2 arms.
- Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
- Duration of Treatment: Treatment was administered before curative surgery for gastric adenocarcinoma or gastric GIST, and postoperative day 5-14 or to discharge whichever occurred first, or consent withdrawal during any time of the study, when the patient would be withdrawn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunomodulating nutrients enriched diet | Experimental | Dietary Supplement: immunomodulating nutrients enriched dietPatients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, enteral nutrition (EN) was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the immunomodulating nutrients enriched diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the interventional diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. |
| standard diet | Active comparator | Dietary Supplement: standard dietPatients received oral feeding with an ordinary diet plus 400 mL/day (400 kcal/day) of the standard diet for 3-5 days before curative surgery for gastric adenocarcinoma or gastric GIST. On postoperative day 3, EN was initiated with 5% glucose in water at a rate of 20 mL/h. On postoperative day 4, patients received a semi-liquid diet plus 400 mL/day (400 kcal/day) of the interventional diet. From postoperative day 5-14 or to discharge whichever occurred first, 1200 mL/day (1200 kcal/day) of the standard diet was administered, and an oral soft diet was also administered if no postoperative complications developed and if oral feeding was not prohibited. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20-85 years old
- Histologically proven primary gastric cancer or GIST.
- Patients was planning to receive elective curative gastric surgery, such as partial gastrectomy, subtotal gastrectomy, proximal gastrectomy, total gastrectomy, etc.
- Patient is able to understand the requirements of the study and written informed consent was obtained from each subject.
Key exclusion criteria (15 listed)
- They were less than 20 years or over 85 years old
- Hepatic dysfunction or bile stasis (serum total bilirubin >2.5 mg/dL)
- Renal dysfunction (serum creatinine >1.5 mg/dL), or required hemodialysis
- Cardiac dysfunction (NYHA functional class >III, or stroke history)
- Severe hypoalbuminemia (albumin <2.5 g/dL)
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 |
|---|---|---|
| immunomodulating nutrients enriched dietAlso: neo-mune | Dietary supplement | immunomodulating nutrients enriched diet |
| standard diet | Dietary supplement | standard diet |
Primary outcome
immunomodulating effects
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
Inflammatory markers including interleukin (IL)-6, C-reactive protein (CRP), and tumor necrosis factor-α (TNF-α) were employed to assess inflammatory processes.
16 secondary outcomes
blood glucose
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood urine nitrogen
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood aspartate aminotransferase (AST) in U/L
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood alanine aminotransferase (ALT) in U/L
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood triglycerides (TG) in mg/dL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood cholesterol in mg/mL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood low-density lipoprotein (LDL) in mg/mL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood high-density lipoprotein (HDL) in mg/mL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood sodium (Na) mEq/L
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood leukocyte count cells/μL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood albumin in g/dL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
blood prealbumin in mg/dL
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
body mass index (BMI) in kg/m^2
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
postoperative complications
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
time to first bowel action
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
length of hospital stay after surgery
Time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first
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 21 Apr 2017.
- 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.
Jaw-Yuan Wang, PhD study chair
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunomodulating nutrients enriched diet and standard diet in people with Gastric Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 4 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 21 Apr 2017. 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 Taiwan. 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?
immunomodulating effects (time frame: at discharge from the hospital or 14 days after surgery, whichever occurred first). 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 21 Apr 2017.