Early IntraVenous Administration of Nutritional Support

NCT03949907 | Terminated DMC

• 1 other identifier: 20190028466
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Stomach; GastroEsophageal Cancer

Keywords

Parenteral Nutrition (PN); Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Overall survival

  12 months

• Treatment-related moderate-severe adverse events as assessed by CTCAE v4.0

  4 months

• Progression-Free Survival (PFS)

  12 months

• Eligibility to second-line chemotherapy

  12 months

• Total dose of chemotherapy administered

  4 months

Other Outcomes (1)

• Serum levels of immunologic profiles

  1 months

Study Arms (2)

Nutritional counseling alone

OTHER

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

Supplemental parenteral nutrition plus nutritional counseling

EXPERIMENTAL

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

Other: Early supplemental parenteral nutrition plus nutritional counseling

Interventions

Nutritional counseling alone OTHER

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

Early supplemental parenteral nutrition plus nutritional counseling OTHER

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.

Supplemental parenteral nutrition plus nutritional counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 32127922 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Hyperphagia; Neoplasms

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Riccardo Caccialanza, MD

  Fondazione IRCCS Policlinico San Matteo

  STUDY CHAIR

• Emanuele Cereda, MD, PhD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

• Paolo Pedrazzoli, MD

  Fondazione IRCCS Policlinico San Matteo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Clinical Nutrition and Dietetics Unit

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 14, 2019
• Study Start: April 14, 2020
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

IT (1)