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

NCT04611113 | Recruiting DMC

• 1 other identifier: 20200060578
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Cancer

Keywords

Immunonutrition; Chemoradiotherapy; Treatment tolerance; Nutritional counseling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Total chemotherapy dose

  9 weeks

• Total radiotherapy dose

  9 weeks

• Duration of treatment

  9 weeks

• Toxicity-free survival

  9 weeks

• Adherence to treatment schedule

  9 weeks

Other Outcomes (1)

• Serum levels of immunologic markers

  9 weeks

Study Arms (2)

Immunonutrition

EXPERIMENTAL

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

Control nutritional support

ACTIVE COMPARATOR

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

Interventions

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 (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.

Immunonutrition

Control Nutritional Support DIETARY_SUPPLEMENT

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.

Control nutritional support

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 29111172 BACKGROUND

• 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.

  PMID: 32936874 BACKGROUND

• 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.

  PMID: 34527079 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Riccardo Caccialanza, MD

  Fondazione IRCCS Policlinico San Matteo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riccardo Caccialanza, MD

CONTACT

0382501615; r.caccialanza@smatteo.pv.it

Emanuele Cereda, MD

CONTACT

0382501615; e.cereda@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 2, 2020
• Study Start: March 17, 2021
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)