Clinical trial NCT03949907: Early IntraVenous Administration of Nutritional Support
Official title: Early IntraVenous Administration of Nutritional Support (IVANS) in Metastatic Gastric, Cancer Patients at Nutritional Risk Undergoing First-line Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Stomach
GastroEsophageal Cancer
Keywords: Parenteral Nutrition (PN)
Cancer
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Combined endpoint - overall survival and weight maintenance
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0
timeFrame: 4 months
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
measure: Eligibility to second-line chemotherapy
timeFrame: 12 months
measure: Total dose of chemotherapy administered
timeFrame: 4 months
measure: Objective response rate
timeFrame: 4 months
measure: Change in body weight
timeFrame: 12 months
measure: Change in handgrip strength
timeFrame: 12 months
measure: Change in muscle mass
timeFrame: 12 months
measure: Change in phase angle
timeFrame: 12 months
measure: Patients requiring unplanned hospitalization
timeFrame: 12 months
measure: Change in self-perceived quality of life
timeFrame: 12 months
measure: Incidence of infections
timeFrame: 12 months
measure: Abnormal values in safety laboratory variables
timeFrame: 12 months
Other outcomes:
measure: Serum levels of immunologic profiles
timeFrame: 1 months
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Riccardo Caccialanza, MD
role: STUDY_CHAIR
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Emanuele Cereda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Policlinico San Matteo
name: Paolo Pedrazzoli, MD
role: STUDY_DIRECTOR
References:
citation: Caccialanza R, Cereda E, Klersy C, Brugnatelli S, Borioli V, Ferrari A, Caraccia M, Lobascio F, Pagani A, Delfanti S, Aprile G, Reni M, Rimassa L, Melisi D, Cascinu S, Battistini L, Candiloro F, Pedrazzoli P. Early intravenous administration of nutritional support (IVANS) in metastatic gastric cancer patients at nutritional risk, undergoing first-line chemotherapy: study protocol of a pragmatic, randomized, multicenter, clinical trial. Ther Adv Med Oncol. 2020 Feb 22;12:1758835919890281. doi: 10.1177/1758835919890281. eCollection 2020.