Back to resultsImmunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer (MURAL)
Primary Purpose
Lung Cancer, Nonsmall Cell
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Immunonutrition
Control dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer, Nonsmall Cell
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immunonutrition
Control dietary intervention
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of response
Time to progression
Overall survival
Overall survival
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
Skeletal muscle mass
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans
Fatigue
Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire
Self-perceived quality of life
Change in quality of life during the study as assessed by validated questionnaires
Self-reported physical activity level
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire
Full Information
NCT ID
NCT05384873
First Posted
May 9, 2022
Last Updated
May 18, 2022
Sponsor
IRCCS Policlinico S. Matteo
Collaborators
San Luigi Gonzaga Hospital, Azienda Ospedaliera Universitaria Integrata Verona, Humanitas Hospital, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05384873
Brief Title
Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
Acronym
MURAL
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
Collaborators
San Luigi Gonzaga Hospital, Azienda Ospedaliera Universitaria Integrata Verona, Humanitas Hospital, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Nonsmall Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immunonutrition
Arm Type
Experimental
Arm Description
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
Arm Title
Control dietary intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Immunonutrition
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control dietary intervention
Intervention Description
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 Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Duration of response
Description
Time to progression
Time Frame
24 months
Title
Overall survival
Description
Overall survival
Time Frame
24 months
Title
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
Description
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0
Time Frame
4 months
Title
Skeletal muscle mass
Description
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans
Time Frame
12 months
Title
Fatigue
Description
Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire
Time Frame
12 months
Title
Self-perceived quality of life
Description
Change in quality of life during the study as assessed by validated questionnaires
Time Frame
12 months
Title
Self-reported physical activity level
Description
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Serum levels of immunologic markers
Description
Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riccardo Caccialanza, MD
Phone
0382501615
Ext
0039
Email
r.caccialanza@smatteo.pv.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra Ferrari, PharmD
Phone
0382503689
Ext
0039
Email
alessandra.ferrari@smatteo.pv.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Caccialanza, MD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee
Learn more about this trial
Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer
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