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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| standard diet | No Intervention | The control group was given no additional postoperative nutritional supplementation (standard diet). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NutrenOpimum | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative malnutrition | the weight loss at 3 months postoperatively to the days 7 postoperatively body weight (body weight loss ratio) higher than 10% | 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 | 1,3,6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| chemotherapy withdrawal | chemotherapy withdrawal by the adverse events or recurrence | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiwei Zhou, Ph.D. | Contact | 86(020)87343626 | zhouzhw@sysucc.org.cn | |
| Runcong Nie, Ph.D. | Contact | 86-15626447119 | nierc@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhiwei Zhou, Ph.D. | SunYat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SunYat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 6 months |
| period of adjuvant chemotherapy | period of adjuvant chemotherapy | 6 months |
| quality of life | quality of life at 1,3 and 6 months as evaluated by EORTC QLQ-C30 | 6 months |
| grade 3/4 neutropenia, thrombocytopenia, anemia | grade 3/4 neutropenia, thrombocytopenia, anemia during adjuvant chemotherapy | 6 months |
| severe side effects on digestive tract | severe side effects on digestive tract during adjuvant chemotherapy | 6 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |