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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Dietary Supplement: Immunonutrition; Dietary Supplement: Control Nutritional Support

• Registration Number: NCT04611113
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

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

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 Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-11-02
• Study Start: 2021-03-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2026-11-15
• Study Completion: 2026-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immunonutrition	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.
Control nutritional support	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.

Primary Outcome Measures

Name	Time	Method
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]	9 weeks	Difference in the incidence of grade \>=3 toxicity, according to CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
Energy intake	9 weeks	Change in energy intake during the study
Total radiotherapy dose	9 weeks	To be calculated as the percentage of radiotherapy dose administered with respect to the treatment plan
Duration of treatment	9 weeks	To be calculated as the percentage of variation of the duration of the chemotherapy and radiotherapy compared to the planned duration
Treatment-related adverse events as assessed by CTCAE v5.0	9 weeks	Difference in the incidence of any toxicity, according to Common Terminology Criteria for Adverse Events \[CTCAE v5.0\]
Skeletal muscle mass	9 weeks	Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans (C3)
Objective response rate	9 weeks	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
Body weight	9 weeks	Change in body weight during the study
Handgrip strength	9 weeks	Change in handgrip strength during the study
Self-perceived quality of life	9 weeks	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 \[EORTC QLQ-C30\]
Patients requiring unplanned hospitalization	9 weeks	The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated
Adherence to treatment schedule	9 weeks	Difference in the proportion of patients completing the treatment schedule as planned
Total chemotherapy dose	9 weeks	To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan
Toxicity-free survival	9 weeks	Difference in the time to onset of moderate-severe adverse events as assessed by CTCAE v5.0
Fatigue	9 weeks	Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire

Trial Locations

Locations (1)

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy