Early IntraVenous Administration of Nutritional Support
- Conditions
- GastroEsophageal CancerCancer of Stomach
- Interventions
- Other: Nutritional counseling aloneOther: Early supplemental parenteral nutrition plus nutritional counseling
- Registration Number
- NCT03949907
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
- histologically confirmed diagnosis of metastatic gastric and gastroesophageal cancer;
- no previous chemotherapy for metastatic disease;
- indication for a first-line chemotherapy with a combination of 2 drugs including platinum derivatives (plus Trastuzumab if HER2+) to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
- measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST);
- presence of nutritional risk (Nutritional Risk Screening 2002 score ≥3);
- availability of permanent venous access (Port, Groshong, PICC);
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- availability of a home parenteral nutrition service to continue nutritional plan as scheduled;
- signed informed consent.
- age <18 years
- ECOG performance status >2
- indication to complete artificial nutrition support (totally compromised spontaneous food-intake)
- contraindication to parenteral nutrition (abnormal glucose and electrolytes control, hyper-triglyceridemia, impaired hemodynamic control and fluid retention)
- availability of jejunostomy for nutritional purposes
- ongoing home artificial nutrition
- unfeasible home parenteral nutrition for social/familial reasons
- absence of caregivers
- patients refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutritional counseling alone Nutritional counseling alone 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. Supplemental parenteral nutrition plus nutritional counseling Early supplemental parenteral nutrition plus nutritional counseling Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
- Primary Outcome Measures
Name Time Method Combined endpoint - overall survival and weight maintenance 12 months A combined endpoint consisting of overall and/or absence of unintentional weight loss \>10% of the weight recorded at enrollment
- Secondary Outcome Measures
Name Time Method Eligibility to second-line chemotherapy 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.
Overall survival 12 months Overall survival
Patients requiring unplanned hospitalization 12 months The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.
Total dose of chemotherapy administered 4 months To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Change in handgrip strength 12 months Change in handgrip strength during the study (at 4 and 12 months)
Change in self-perceived quality of life 12 months 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 \[EORTC QLQ-C30\]
Incidence of infections 12 months The rate of incident infections in each group and the related difference will be calculated
Progression-Free Survival (PFS) 12 months 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.
Change in body weight 12 months Change in body weight during the study (at 4 and 12 months)
Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0 4 months Difference in the incidence of grade \>=3 toxicity, according to Common Terminology Criteria for Adverse Events \[CTCAE v4.0\]
Objective response rate 4 months 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 phase angle 12 months Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis
Change in muscle mass 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
Abnormal values in safety laboratory variables 12 months The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups
Trial Locations
- Locations (1)
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy