Early IntraVenous Administration of Nutritional Support (IVANS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer of Stomach; GastroEsophageal Cancer
• Intervention / Treatment: Other: Nutritional counseling alone; Other: Early supplemental parenteral nutrition plus nutritional counseling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riccardo Caccialanza, MD; Phone Number: +390382501615; Email: r.caccialanza@smatteo.pv.it
• Study Contact Backup: Name: Emanuele Cereda, MD, PhD; Phone Number: +390382501615; Email: e.cereda@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione Irccs Policlinico San Matteo
    • Contact: Riccardo Caccialanza, MD
    • Principal Investigator: Riccardo Caccialanza, MD
    • Sub-Investigator: Emanuele Cereda, MD, PhD
    • Sub-Investigator: Paolo Pedrazzoli, MD
    • Sub-Investigator: Silvia Brugnatelli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: Nutritional counseling alone; 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.
Experimental: Supplemental parenteral nutrition plus nutritional counseling; Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.	Other: Early supplemental parenteral nutrition plus nutritional counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined endpoint - overall survival and weight maintenance	A combined endpoint consisting of overall and/or absence of unintentional weight loss >10% of the weight recorded at enrollment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	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.	12 months
Overall survival	Overall survival	12 months
Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0	Difference in the incidence of grade >=3 toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v4.0]	4 months
Eligibility to second-line chemotherapy	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.	12 months
Total dose of chemotherapy administered	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan	4 months
Objective response rate	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.	4 months
Change in body weight	Change in body weight during the study (at 4 and 12 months)	12 months
Change in handgrip strength	Change in handgrip strength during the study (at 4 and 12 months)	12 months
Change in muscle mass	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	12 months
Change in phase angle	Change in phase angle during the study (at 4 and 12 months) evaluated with bioimpedance vectorial analysis	12 months
Patients requiring unplanned hospitalization	The rate of patients requiring unplanned hospitalization (one or more) at 12 months will be calculated.	12 months
Change in self-perceived quality of life	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]	12 months
Incidence of infections	The rate of incident infections in each group and the related difference will be calculated	12 months
Abnormal values in safety laboratory variables	The number of participants with abnormal values in safety laboratory variables will be calculated and compared between groups	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum levels of immunologic profiles	Levels of soluble effectors and immunoregulatory cells at 1 week and 1 month from the start of chemotherapy	1 months

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Investigators: Principal Investigator: Emanuele Cereda, MD, PhD, Fondazione Irccs Policlinico San Matteo; Study Chair: Riccardo Caccialanza, MD, Fondazione Irccs Policlinico San Matteo; Study Director: Paolo Pedrazzoli, MD, Fondazione Irccs Policlinico San Matteo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Parenteral Nutrition (PN)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 20190028466

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No