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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Dietary Supplement: Immunonutrition
* Dietary Supplement: Control Nutritional Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunonutrition<br>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<br>* 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.<br>|
| Active Comparator: Control nutritional support<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunonutrition, Chemoradiotherapy, Treatment tolerance, Nutritional counseling