Immunonutrition and Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

Efficacy of Immunonutrition in Improving Tolerance to Chemoradiotherapy in Patients With Head-neck Cancer

The aim of the present project is to evaluate in a randomised, controlled, open-label, two parallel treatment groups pilot study, the efficacy of oral nutritional supplementation with a high-protein-high calorie mixture containing immunonutrients compared to a standard high-calorie-high-protein nutritional blend, in addition to nutritional counseling, in improving tolerance to chemoradiotherapy (CT-RT) in patients with tumours of the head and neck

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Dietary supplement: Immunonutrition; Dietary supplement: Control Nutritional Support

Detailed Description

In a recent study, we have shown that the systematic use of oral nutritional supplements (ONS) in combination with counseling further favours the maintenance of nutrition status, the recovery of quality of life and, more importantly, improves the practicability of CT-RT. This effect would be substantially attributable to the increase in protein-energy intake associated with ONS use, but also to the possible "nutraceutical" action of omega-3 fatty acids. Therefore, modulation of the inflammatory response could play a role during cancer treatments. In this context, there is an already-known high-calorie-high-protein nutritional blend, enriched in immunonutrients (arginine, nucleotides and omega-3 fatty acids), which could also have an application in this type of patients. This mixture has proven effective in reducing the risk of post-operative complications (e.g. infections, fistulas, etc.) and the length of stay of patients undergoing major cancer surgery (abdominal and head and neck regions). Nevertheless, in oncology, there is a growing therapeutic interest in the modulation of inflammation and immunosuppression at the tumour microenvironment level.

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riccardo Caccialanza, MD; Phone Number: +39 0382501615; Email: r.caccialanza@smatteo.pv.it
• Study Contact Backup: Name: Emanuele Cereda, MD; Phone Number: +39 0382501615; Email: e.cereda@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Riccardo Caccialanza, MD
    • Principal Investigator: Riccardo Caccialanza, MD
    • Sub-Investigator: Emanuele Cereda, MD, PhD
    • Sub-Investigator: Paolo Pedrazzoli, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosis of head-neck cancer
• indication to curative or adjuvant chemoradiotherapy
• availability to planned measurements and to written informed consent.

Exclusion Criteria:

• age <18 years
• indication to or ongoing artificial nutrition
• refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

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 (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.	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 (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.
Active Comparator: Control nutritional support; In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement. The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.	Dietary supplement: Control Nutritional Support; In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement. The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total chemotherapy dose	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan	9 weeks
Total radiotherapy dose	To be calculated as the percentage of radiotherapy dose administered with respect to the treatment plan	9 weeks
Duration of treatment	To be calculated as the percentage of variation of the duration of the chemotherapy and radiotherapy compared to the planned duration	9 weeks
Toxicity-free survival	Difference in the time to onset of moderate-severe adverse events as assessed by CTCAE v5.0	9 weeks
Adherence to treatment schedule	Difference in the proportion of patients completing the treatment schedule as planned	9 weeks
Treatment-related adverse events as assessed by CTCAE v5.0	Difference in the incidence of any toxicity, according to Common Terminology Criteria for Adverse Events [CTCAE v5.0]	9 weeks
Objective response rate	Defined as a complete response or partial response confirmed by a subsequent assessment no earlier than 2 months after the initial documentation. Response is assessed in patients with a measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) criteria	9 weeks
Body weight	Change in body weight during the study	9 weeks
Energy intake	Change in energy intake during the study	9 weeks
Handgrip strength	Change in handgrip strength during the study	9 weeks
Skeletal muscle mass	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans (C3)	9 weeks
Self-perceived quality of life	Change in quality of life during the study as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 [EORTC QLQ-C30]	9 weeks
Fatigue	Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire	9 weeks
Patients requiring unplanned hospitalization	The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated	9 weeks

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	9 weeks

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Principal Investigator: Riccardo Caccialanza, MD, Fondazione IRCCS Policlinico San Matteo

Publications and helpful links

General Publications

• Cereda E, Cappello S, Colombo S, Klersy C, Imarisio I, Turri A, Caraccia M, Borioli V, Monaco T, Benazzo M, Pedrazzoli P, Corbella F, Caccialanza R. Nutritional counseling with or without systematic use of oral nutritional supplements in head and neck cancer patients undergoing radiotherapy. Radiother Oncol. 2018 Jan;126(1):81-88. doi: 10.1016/j.radonc.2017.10.015. Epub 2017 Oct 27.
• Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.
• Caccialanza R, Cereda E, Klersy C, Nardi M, Masi S, Crotti S, Cappello S, Caissutti V, Brovia C, Lobascio F, Formisano E, Colombo S, Filippi AR, Bonzano E, Comoli P, Catenacci L, Alberti A, Musella V, Ferrari A, Imarisio I, Tancredi R, Monaco T, Ghi MG, Bossi P, Pedrazzoli P. The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. Ther Adv Med Oncol. 2021 Sep 11;13:17588359211025872. doi: 10.1177/17588359211025872. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2021
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

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

• Keywords: Immunonutrition; Chemoradiotherapy; Nutritional counseling; Treatment tolerance
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 20200060578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• 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