Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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Oral Nutritional Supplements Compared With Standard Diet in Postoperative Gastric Cancer Patients With Adjuvant Chemotherapy: a Multicenter, Open-label, Phase 3 Randomised Controlled Trial

Conditions
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Gastric Cancer

Intervention / Treatment
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* Dietary Supplement: NutrenOpimum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral nutritional supplements<br>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. | Dietary Supplement: NutrenOpimum<br>* 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.<br>|
| No Intervention: standard diet<br>The control group was given no additional postoperative nutritional supplementation (standard diet). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, chemothrapy, oral nutritional supplements, malnutrition