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NCT Number: NCT05384873

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

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

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Key information

Conditions

Lung Cancer, Nonsmall Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location status: Recruiting

Location contact

Riccardo Caccialanza, MD

CONTACT

[email protected]

+390382501615

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunonutrition

Dietary Supplement

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

Control dietary intervention

Other

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.

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 12 months

    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.

Secondary outcomes

  1. Duration of response

    Time frame: 24 months

    Time to progression

  2. Overall survival

    Time frame: 24 months

    Overall survival

  3. Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]

    Time frame: 4 months

    Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0

  4. Skeletal muscle mass

    Time frame: 12 months

    Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans

  5. Fatigue

    Time frame: 12 months

    Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire

  6. Self-perceived quality of life

    Time frame: 12 months

    Change in quality of life during the study as assessed by validated questionnaires

  7. Self-reported physical activity level

    Time frame: 12 months

    Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire

Other outcomes

  1. Serum levels of immunologic markers

    Time frame: 12 months

    Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Ferrari, PharmD

CONTACT

[email protected]

0382503689 ext. 0039

Riccardo Caccialanza, MD

CONTACT

[email protected]

0382501615 ext. 0039

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona
  • Humanitas Hospital, Italy
  • San Luigi Gonzaga Hospital

Registry information

Official study title

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

Acronym: MURAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 20, 2022
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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