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Olive

Nutritional counseling consists of a personalized dietary prescription with regular consultation by a registered dietitian and telephone interviews, as well as of the use of oral nutritional supplements, when necessary.

Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.

Nutritional counseling consists of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences, in order to achieve estimated protein-calorie requirements and to take into account chewing and swallowing abilities. Regular consultation by a registered dietitian will be also provided every 10 days by means of face-to-face interviews (at scheduled follow-up visits - chemotherapy cycle) and telephone interviews (planned between chemotherapy cycles and as required by the patient). In the presence of significant reduction of normal food intake, the use of oral nutritional supplements will be also considered.

In the presence of body weight loss \>10% of the weight recorded at enrollment, patients allocated to this group group will be censored and treated according to current supportive care guidelines, including home parenteral nutrition.

Nutritional counseling alone

Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.

Supplemental home parenteral nutrition will be prescribed, provided daily and adjusted throughout the study (approximately every 10 days, until the end of the scheduled first-line chemotherapy) according to estimated protein-calorie oral intakes, in order to satisfy estimated requirements. Home parenteral nutrition will be infused mainly during night hours, using multi-chamber bags containing olive oil-based lipid emulsions, when not contraindicated.

Early supplemental parenteral nutrition plus nutritional counseling

Riccardo Caccialanza, MD

Emanuele Cereda, MD, PhD

Paolo Pedrazzoli, MD

Silvia Brugnatelli, MD

The present trial will be conducted to verify if early supplemental parenteral nutrition in combination with nutritional counseling improves survival and the feasibility of chemotherapy, in addition to nutritional status, body composition, functional status and quality of life in treatment-naïve patients with metastatic gastric cancer at nutritional risk undergoing first-line chemotherapy.

Although it is known that nutritional support can improve clinical outcomes, the literature shows that only around 50% of cancer patients are able to satisfy estimated protein-calorie requirements. It is also emerging a strong correlation between nutritional status, particularly body composition, and adherence to active treatment. International guidelines suggest that parenteral nutrition (PN) is recommended in malnourished, hypophagic cancer patients suffering from gastrointestinal complications or with expected prolonged inadequate food intake, when enteral nutrition is not feasible. Although recent trials suggest that supplemental PN (SPN) could help to improve the nutritional status of malnourished cancer patients, there are no studies on the clinical effects of early SPN in cancer patients at nutritional risk receiving first-line chemotherapy.

Early IntraVenous Administration of Nutritional Support

Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy

Levels of soluble effectors and immunoregulatory cells at 1 week and 1 month from the start of chemotherapy

A combined endpoint consisting of overall and/or absence of unintentional weight loss \>10% of the weight recorded at enrollment

Difference in the incidence of grade \>=3 toxicity, according to Common Terminology Criteria for Adverse Events \[CTCAE v4.0\]

A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months.

The rate of patients eligible for second-line chemotherapy at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and eligible or not eligible or dead at 12 months.

To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan

Defined as a complete response or partial response that has been confirmed by a subsequent assessment no earlier than 2 months after the initial documentation. Response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Change in body weight during the study (at 4 and 12 months)

Change in handgrip strength during the study (at 4 and 12 months)

Change in muscle mass during the study (at 4 and 12 months) evaluated with computed tomography scan at the level of the third lumbar vertebra

Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis

The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.

Change in self-perceived quality of life during the study (at 4 and 12 months) as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 \[EORTC QLQ-C30\]

The rate of incident infections in each group and the related difference will be calculated

The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups

Spots Global Cancer Trial Database for early supplemental parenteral nutrition plus nutritional counseling