Gastric CancerPhase 3NCT00606619
Effects of Early Oral Feeding After Resection of Gastric Cancer
A Phase 3 study testing Conventional feeding and Early oral feeding in people with Gastric Cancer, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Conventional feeding and Early oral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Feb 2009
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent gastrectomy for adenocarcinoma of stomach with following criteria:
- Performed curative resection
- Have The American Society of Anaesthesiologists (ASA) score of less than 3
Who cannot join
- Patients who have simultaneously other cancer.
- Patients who underwent gastric resection at past time.
- Patients who have cancer with bleeding or perforation or obstruction.
- Patients who have any injury to the pancreas capsule on operation.
- Patients who get pregnancy.
- Patients who are treating diabetics with Insulin.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
St Mary's Hospital, The Catholic University of Korea
Seoul, 150-713
About this study
Official title: Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
Read the detailed description
Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.
- Conditions
- Gastric Cancer
- Being tested
- Conventional feeding, Early oral feeding
- Keywords
- Gastrectomy, Oral feeding, Nutrition, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional feedingOther
Procedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day.
Early oral feedingOther
Procedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Conventional feeding : They begin ingesting sips of water on third postoperative day and continued with a liquid diet for the next two days. Patients were given a soft diet on sixth postoperative day. Receives: Other: Conventional feeding |
| 2 | Experimental | Early oral feeding : The patients begin ingesting sips of water on the first postoperative day. If they are tolerable, they continued with a clear liquid diet the next day and a soft diet on the third post operative day. Receives: Other: Early oral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of hospital stay after operation
We measure the length of hospital stay after operation
Measured: within 30 days after operation
Secondary outcomes (7)
Day of recovery of bowel sound and flatus: Evidence of recovery of bowel sound by physician's examination and Evidence of first flatus by question to patient
We measure the days of flatus within 30 days after operation
Measured: within 30 days after operation
Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured
Measured: 1,3,5 and 7 day after operation
Symptom of Patients: Question to patients about symptoms
Measured: before operation and 1,3,5,7 day after operation
Cost effectiveness: Total cost duration of hospitalization
We measure total cost from admission to discharge after operation
Measured: within 30 days after admission
Quality of life: EORTC QLQ30, STO22
Measured: 1,2 and 3 month after operation
Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
Measured: before operation and 1,3,5,7 day after operation
Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
We observe the occurrence of morbidity after operation
Measured: within 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Investigators
- Hae Myung Jeon, MD, Principal investigator, Department of Surgery, St Mary's Hospital, The Catholic University of KoreaHoon Hur, MD, Study director, Department of Surgery, St Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606619
- Sponsor's protocol ID
- SCMC07OT135
- Status last verified
- Feb 2009
- First submitted
- 22 Jan 2008
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Suehiro T, Matsumata T, Shikada Y, Sugimachi K. Accelerated rehabilitation with early postoperative oral feeding following gastrectomy. Hepatogastroenterology. 2004 Nov-Dec;51(60):1852-5.
PubMed 15532842Gabor S, Renner H, Matzi V, Ratzenhofer B, Lindenmann J, Sankin O, Pinter H, Maier A, Smolle J, Smolle-Juttner FM. Early enteral feeding compared with parenteral nutrition after oesophageal or oesophagogastric resection and reconstruction. Br J Nutr. 2005 Apr;93(4):509-13. doi: 10.1079/bjn20041383.
PubMed 15946413Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
PubMed 7618972Hur H, Si Y, Kang WK, Kim W, Jeon HM. Effects of early oral feeding on surgical outcomes and recovery after curative surgery for gastric cancer: pilot study results. World J Surg. 2009 Jul;33(7):1454-8. doi: 10.1007/s00268-009-0009-3.
PubMed 19399550
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial for Effect Early Oral Feeding on Recovery After Resection of Gastric Cancer
- ClinicalTrials.gov ID
- NCT00606619
- Acronym / sponsor ID
- SCMC07OT135
- Conditions
- Gastric Cancer
- Keywords
- Gastrectomy, Oral feeding, Nutrition, Gastric cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 4 Feb 2008 (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.
The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
Detailed description
Most patients who undergo gastric resection for gastric cancer have maintained going on a fast of over three days after operation. Surgeons have believed that early oral feeding might worsen patients' condition by prolonged postoperative ileus. Therefore, patients received nothing by oral route until resolution of the ileus. However, the current trend toward minimal operative injury and early discharge from hospital. In addition, development of operative technique and instrument make the operation time to be short and the patients to be fast recovery, and thus it is possible to feed early in less than two days after operation. The aim of this study is to determine whether early oral feeding after curative resection for gastric cancer would be tolerable and give an effect on the recovery.
We collect fifty-eight patients for this study and divide into two groups using randomization method. In the early feeding group, patients will receive the liquid diet two day after operation followed by soft diet postoperative three day. Meanwhile, the patients who categorized into control group will start the liquid diet postoperative four day followed by soft diet postoperative six day. We evaluate the morbidity or mortality rate and laboratory findings. Of course, it is supposed to be same in amount of fluid and calories between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Other: Conventional feedingConventional feeding : They begin ingesting sips of water on third postoperative day and continued with a liquid diet for the next two days. Patients were given a soft diet on sixth postoperative day. |
| 2 | Experimental | Other: Early oral feedingEarly oral feeding : The patients begin ingesting sips of water on the first postoperative day. If they are tolerable, they continued with a clear liquid diet the next day and a soft diet on the third post operative day. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Performed curative resection
- Have The American Society of Anaesthesiologists (ASA) score of less than 3
Key exclusion criteria (6 listed)
- Patients who have simultaneously other cancer.
- Patients who underwent gastric resection at past time.
- Patients who have cancer with bleeding or perforation or obstruction.
- Patients who have any injury to the pancreas capsule on operation.
- Patients who get pregnancy.
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 |
|---|---|---|
| Conventional feedingProcedure of Conventional feeding group: Patients are supplied water on day 3 after operation, liquid diet on day 4 and 5 and soft diet on 6 day. | Other | 1 |
| Early oral feedingProcedure of Early oral feeding group: Patients are supplied water on day 1 after operation, liquid diet on day 2 and soft diet on day 3 day. | Other | 2 |
Primary outcome
Days of hospital stay after operation
Time frame: within 30 days after operation
We measure the length of hospital stay after operation
7 secondary outcomes
Day of recovery of bowel sound and flatus: Evidence of recovery of bowel sound by physician's examination and Evidence of first flatus by question to patient
Time frame: within 30 days after operation
Laboratory findings after operation: Albumin, complete blood count, total cholesterol, cholinesterase and C-reactive protein are measured
Time frame: 1,3,5 and 7 day after operation
Symptom of Patients: Question to patients about symptoms
Time frame: before operation and 1,3,5,7 day after operation
Cost effectiveness: Total cost duration of hospitalization
Time frame: within 30 days after admission
Quality of life: EORTC QLQ30, STO22
Time frame: 1,2 and 3 month after operation
Immunologic Outcomes : IL-1, IL-2, IL-6, IL-8, TNF-a will by measured by ELISA
Time frame: before operation and 1,3,5,7 day after operation
Postoperative morbidity rate in hospital days: Clinically definite morbidity confirmed by physicians according to offered protocol
Time frame: within 30 days after operation
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 28 May 2010.
- Background: PubMed 15532842Suehiro T, Matsumata T, Shikada Y, Sugimachi K. Accelerated rehabilitation with early postoperative oral feeding following gastrectomy. Hepatogastroenterology. 2004 Nov-Dec;51(60):1852-5.
- Background: PubMed 15946413Gabor S, Renner H, Matzi V, Ratzenhofer B, Lindenmann J, Sankin O, Pinter H, Maier A, Smolle J, Smolle-Juttner FM. Early enteral feeding compared with parenteral nutrition after oesophageal or oesophagogastric resection and reconstruction. Br J Nutr. 2005 Apr;93(4):509-13. doi: 10.1079/bjn20041383.
- Background: PubMed 7618972Reissman P, Teoh TA, Cohen SM, Weiss EG, Nogueras JJ, Wexner SD. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial. Ann Surg. 1995 Jul;222(1):73-7. doi: 10.1097/00000658-199507000-00012.
- Derived from this study: PubMed 19399550Hur H, Si Y, Kang WK, Kim W, Jeon HM. Effects of early oral feeding on surgical outcomes and recovery after curative surgery for gastric cancer: pilot study results. World J Surg. 2009 Jul;33(7):1454-8. doi: 10.1007/s00268-009-0009-3.
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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.
Hae Myung Jeon, MD principal investigator
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
Hoon Hur, MD study director
Department of Surgery, St Mary's Hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional feeding and Early oral feeding in people with Gastric Cancer, run by The Catholic University of 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 3 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 28 May 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Days of hospital stay after operation (time frame: within 30 days after operation). 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 NCT00606619, which also lists 4 linked publications.
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 28 May 2010.