Individualization of Nutritive Sensory Support Of Radiation Therapy

Study Overview
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Brief Summary
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Nutritional deficiency and subsequent weight loss in patients with head and neck cancer is a common problem and a negative predictor of treatment outcomes and mortality, as well as quality of life. Nutritional support for patients is a prerequisite for the successful management of cancer patients. Sensory changes can be side effects of chemotherapy or ionizing radiation, which damages sensory receptors in the area of radiation, disrupts the function of the salivary glands, leading to hyposalivation and a decrease in taste. Individual choice of nutrition based on sensory sensations can significantly improve the quality of life of patients and ensure timely correction of their eating behavior.

Official Title
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Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy

Conditions
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Radiotherapy; Complications, Head and Neck Cancer

Intervention / Treatment
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* Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet
* Dietary Supplement: ONS without a sensor component and taste + standard diet
* Dietary Supplement: Standard diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years The presence of morphological verification of squamous cell carcinoma of the head and neck No history of anticancer treatment ECOG score 0 - 2 Life expectancy is more than 3 months Normal liver, kidney and bone marrow function Absence of severe uncontrolled concomitant chronic diseases and acute diseases (including infectious diseases) Absence of pregnancy, lactation Initial compliance of patients (according to the consultation of a psychologist and questionnaires) with a signed informed consent Exclusion Criteria: Simultaneous participation in another clinical trial Failure to meet inclusion criteria The patient's condition is ECOG ≥3, Karnovsky ≤40%. Bleeding Decay / Abscess in the area of tumor lesion Pregnancy or breastfeeding Refractory cachexia Allergy or intolerance to any of the components of ONS

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>50 patients with squamous cell head cancer over 18 years of age, receiving chemoradiation therapy, receiving 3 bottles (х 200 ml) of ONS with Protein Oncosensation with a neutral taste throughout the course of treatment. | Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet<br>* ONS with a cooling effect and Red Fruits taste. 3 bottles (х 200 ml) per day X 14 days (at severe mucositis period) in addition to a standard diet and other ONS without a sensor component and taste according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day)<br>|
| Active Comparator: Prospective Control group<br>50 patients over 18 years of age with squamous cell carcinoma of the head and neck, receiving chemoradiation therapy, receiving standard nutritional therapy with a neutral taste throughout the course of treatment. | Dietary Supplement: ONS without a sensor component and taste + standard diet<br>* Nutritional support + ONS without a sensor component and taste (cooling effect) in addition to a standard diet according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day)<br>|
| Sham Comparator: Retrospective Control group<br>60 patients who received chemoradiotherapy earlier with standard nutritional support. | Dietary Supplement: Standard diet<br>* Without appropriate nutritional support - not in accordance with current ESPEN guidelines (protein and Energy intake less than 1.5 g/kg/day and 25 and 30 kcal/kg/day). (Historical retrospective control).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QoL) | QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F) | 1 year | 
| Nutritional status | Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002 | 1 year | 
| Patient compliance | The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance to chemoradiation therapy - mucositis | Mucositis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | 4 months | 
| Tolerance to chemoradiation therapy - dermatitis | Dermatitis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | 4 months | 
| Terms of treatment | Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one. | during radiation treatment | 
| Unplanned breaks | Days of delayed treatment | during radiation treatment | 
| Efficiency of chemoradiation therapy | Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). | 1 year | 
| 1-year locoregional control | 1-year locoregional control after chemoradiation therapy | 1 year | 
| 1-year overall survival | 1-year overall survival is the percentage of people who are alive one year after they started chemoradiation therapy | 1 year | 
| 1-year relapse-free survival | 1-year relapse-free survival is the percentage of people who have not had relaps one year after they started chemoradiation therapy | 1 year | 
| Dynamics of sensory changes | Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale) | 1 year | 
| Dynamics of pain syndrome | Dynamics of pain syndrome based on numerical rating scale (NRS scale) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional support, Radiotherapy, Head and Neck Cancer, Complications