Gastric CancerPhase 3NCT03654534
Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy
A Phase 3 study testing NutrenOpimum in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- NutrenOpimum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2019to 15 Jun 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be proven to be primary adenocarcinoma of gastric cancer and pathological confirmed stage II-III or T1N1M0
- age: 18-75 years
- Eastern Cooperative Oncology Group performance status: 0~2
- body mass index: 18.5-28.0kg/m2
- able to ingest semiliquid diet
- without other malignancies with exception of the cured cervical carcinoma in situ and basal cell carcinoma
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- anticipated overall survival time ≥ 6 months
- anticipated period of adjuvant chemotherapy ≥ 3
- without severe mental disorder
- without severe digestive disease
- without Acquired Immune Deficiency Syndrome or diabetes mellitus
- without communication barrier
- informed consensus of patients
Who cannot join
- with unstable hemodynamics
- with severe nausea or vomit which cannot be controlled by drugs
- allergic reaction to NutrenOpimum
- dysfunction of other organs
- with severe disease, such as infection, stroke, heart failure or stock
- other situation to be judged not adaptive to the study by investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SunYat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhiwei Zhou, Ph.D., 86-1390222289, zhouzhw@sysucc.org.cn
Runcong Nie, Ph.D., 86-15626447119, nierc@sysucc.org.cn
About this study
Official title: Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy: a Multicenter, Open-label, Phase 3 Randomised Controlled Trial
Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. A multi-institutional prospective phase 2 study had demonstrated the efficacy of oral nutritional supplements (ONS) for gastric cancer patients undergoing gastrectomy. However, previous studies did not focus the gastric cancer patients with adjuvant chemotherapy. Thus, it is unknown whether the ONS could benefit the gastric cancer patients with adjuvant chemotherapy. A multicenter, phase 3 randomised controlled trial was conducted to compare the ONS with standard diet for postoperative gastric cancer patients with adjuvant chemotherapy. Patients and method: In this study, pathological confirmed stage II-III or T1N1M0 gastric cancer patients who are supposed to receive adjuvant chemotherapy, aged from 18 to 75 years, with body mass index (BMI) from 18.5 to 28.0 kg/m2, and with Eastern Cooperative Oncology Group performance status ≤2, are randomized 1:1 to receive oral administration of NutrenOpimum (Nestle Suisse S.A.), a liquid enteral nutritional food for special medical purpose (FSMP), or standard diet. NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was postoperative malnutrition, as defined as ratio of the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%; body weight loss ratio at 1, 3, 6 months. Secondary end points were chemotherapy withdrawal, time to adjuvant chemotherapy failure, period of adjuvant chemotherapy, quality of life, grade 3/4 neutropenia, thrombocytopenia, anemia, and severe side effects on digestive tract. Final study analysis will be conducted after the last patient's enrollment.
- Conditions
- Gastric Cancer
- Being tested
- NutrenOpimum
- Keywords
- gastric cancer, chemothrapy, oral nutritional supplements, malnutrition
- Medical subject headings
- Stomach Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrenOpimumDietary supplement
NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| oral nutritional supplements | Experimental | NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. Receives: Dietary Supplement: NutrenOpimum |
| standard diet | No intervention | The control group was given no additional postoperative nutritional supplementation (standard diet). |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative malnutrition
the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%
Measured: 3 months postoperatively
body weight loss ratio at 1, 3, 6 months
the ratio of the weight loss at 1,3,6 months postoperatively to the days 7 postoperatively body weight
Measured: 1,3,6 months postoperatively
Secondary outcomes (6)
chemotherapy withdrawal
chemotherapy withdrawal by the adverse events or recurrence
Measured: 6 months
time to adjuvant chemotherapy failure
Time to adjuvant treatment chemotherapy failure (TTF) were calculated using the Kaplan-Meier method and compared by the log-rank test
Measured: 6 months
period of adjuvant chemotherapy
period of adjuvant chemotherapy
Measured: 6 months
quality of life
quality of life at 1,3 and 6 months as evaluated by EORTC QLQ-C30
Measured: 6 months
grade 3/4 neutropenia, thrombocytopenia, anemia
grade 3/4 neutropenia, thrombocytopenia, anemia during adjuvant chemotherapy
Measured: 6 months
severe side effects on digestive tract
severe side effects on digestive tract during adjuvant chemotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Apr 2019
- Primary completion16 Sep 2020 (estimated)
- Study completion15 Jun 2021 (estimated)
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 Sun Yat-sen 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Zhiwei, Sun Yat-sen University
- Investigators
- Zhiwei Zhou, Ph.D., Study chair, SunYat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654534
- Sponsor's protocol ID
- SYSUCCGPS3
- Status last verified
- Apr 2019
- First submitted
- 30 Aug 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy: a Multicenter, Open-label, Phase 3 Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03654534
- Acronym / sponsor ID
- SYSUCCGPS3
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, chemothrapy, oral nutritional supplements, malnutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 16 Sep 2020 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 31 Aug 2018 (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.
Background: It is known that postoperative malnutrition remains inevitable for gastric cancer patients with adjuvant chemotherapy, which could have prejudicial influence on the compliance of subsequent adjuvant chemotherapy and survival of the patients. A multi-institutional prospective phase 2 study had demonstrated the efficacy of oral nutritional supplements (ONS) for gastric cancer patients undergoing gastrectomy. However, previous studies did not focus the gastric cancer patients with adjuvant chemotherapy. Thus, it is unknown whether the ONS could benefit the gastric cancer patients with adjuvant chemotherapy. A multicenter, phase 3 randomised controlled trial was conducted to compare the ONS with standard diet for postoperative gastric cancer patients with adjuvant chemotherapy. Patients and method: In this study, pathological confirmed stage II-III or T1N1M0 gastric cancer patients who are supposed to receive adjuvant chemotherapy, aged from 18 to 75 years, with body mass index (BMI) from 18.5 to 28.0 kg/m2, and with Eastern Cooperative Oncology Group performance status ≤2, are randomized 1:1 to receive oral administration of NutrenOpimum (Nestle Suisse S.A.), a liquid enteral nutritional food for special medical purpose (FSMP), or standard diet. NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. The primary end point was postoperative malnutrition, as defined as ratio of the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%; body weight loss ratio at 1, 3, 6 months. Secondary end points were chemotherapy withdrawal, time to adjuvant chemotherapy failure, period of adjuvant chemotherapy, quality of life, grade 3/4 neutropenia, thrombocytopenia, anemia, and severe side effects on digestive tract. Final study analysis will be conducted after the last patient's enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral nutritional supplements | Experimental | Dietary Supplement: NutrenOpimumNutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. |
| standard diet | No intervention | –The control group was given no additional postoperative nutritional supplementation (standard diet). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- be proven to be primary adenocarcinoma of gastric cancer and pathological confirmed stage II-III or T1N1M0
- age: 18-75 years
- Eastern Cooperative Oncology Group performance status: 0~2
- body mass index: 18.5-28.0kg/m2
- able to ingest semiliquid diet
Key exclusion criteria (6 listed)
- with unstable hemodynamics
- with severe nausea or vomit which cannot be controlled by drugs
- allergic reaction to NutrenOpimum
- dysfunction of other organs
- with severe disease, such as infection, stroke, heart failure or stock
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 |
|---|---|---|
| NutrenOpimumNutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively. | Dietary supplement | oral nutritional supplements |
Primary outcome
postoperative malnutrition
Time frame: 3 months postoperatively
the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10%
body weight loss ratio at 1, 3, 6 months
Time frame: 1,3,6 months postoperatively
the ratio of the weight loss at 1,3,6 months postoperatively to the days 7 postoperatively body weight
6 secondary outcomes
chemotherapy withdrawal
Time frame: 6 months
time to adjuvant chemotherapy failure
Time frame: 6 months
period of adjuvant chemotherapy
Time frame: 6 months
quality of life
Time frame: 6 months
grade 3/4 neutropenia, thrombocytopenia, anemia
Time frame: 6 months
severe side effects on digestive tract
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- 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.
Zhiwei Zhou, Ph.D. study chair
SunYat-sen University
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 NutrenOpimum in people with Gastric Cancer, run by Sun Yat-sen 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 13 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiwei Zhou, Ph.D. (86(020)87343626, zhouzhw@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative malnutrition (time frame: 3 months postoperatively). The study lists 2 primary outcomes in all. 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 17 Apr 2019.