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Early IntraVenous Administration of Nutritional Support

NCT03949907 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Riccardo Caccialanza, MD · Fondazione IRCCS Policlinico San Matteo

  • Emanuele Cereda, MD, PhD · Fondazione IRCCS Policlinico San Matteo

  • Paolo Pedrazzoli, MD · Fondazione IRCCS Policlinico San Matteo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2024-07-30
Completion
2024-07-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03949907 on ClinicalTrials.gov