Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer (MURAL)

Multicentre, Randomised, Open-label, Parallel-group Trial to Evaluate Immunonutrition in Improving Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer, Undergoing Systematic Nutritional Counseling

The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer, Nonsmall Cell
• Intervention / Treatment: Dietary supplement: Immunonutrition; Other: Control dietary intervention

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riccardo Caccialanza, MD; Phone Number: 0039 0382501615; Email: r.caccialanza@smatteo.pv.it
• Study Contact Backup: Name: Alessandra Ferrari, PharmD; Phone Number: 0039 0382503689; Email: alessandra.ferrari@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Riccardo Caccialanza, MD; Phone Number: +390382501615; Email: r.caccialanza@smatteo.pv.it

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology);
• First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines;
• Will to participate by providing written informed consent;
• Availability to administer oral supplements and immunotherapy with or without chemotherapy;
• Eastern Cooperative Oncology Group Performance Status ≤ 2;
• Life expectancy ≥ 6 months.

Exclusion Criteria:

• Age < 18 years;
• Inability to sign an informed consent;
• Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immunonutrition; In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs	Dietary supplement: Immunonutrition; In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs
Active Comparator: Control dietary intervention; Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake.	Other: Control dietary intervention; Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake.

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	24 months
Duration of response	Time to progression	24 months
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]	Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0	4 months
Skeletal muscle mass	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans	12 months
Fatigue	Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire	12 months
Self-perceived quality of life	Change in quality of life during the study as assessed by validated questionnaires	12 months
Self-reported physical activity level	Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum levels of immunologic markers	Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays	12 months

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona; San Luigi Gonzaga Hospital; Humanitas Hospital, Italy
• Investigators: Principal Investigator: Riccardo Caccialanza, MD, Fondazione IRCCS Policlinico San Matteo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 0020364/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No