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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
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)
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)
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).
P. Hertsen Moscow Oncology Research Institute
Moscow, Russia
Quality of life (QoL)
QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Time frame: 1 year
Nutritional status
Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002
Time frame: 1 year
Patient compliance
The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.
Time frame: 1 year
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
Time frame: 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
Time frame: 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.
Time frame: during radiation treatment
Unplanned breaks
Days of delayed treatment
Time frame: during radiation treatment
Efficiency of chemoradiation therapy
Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Time frame: 1 year
1-year locoregional control
1-year locoregional control after chemoradiation therapy
Time frame: 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
Time frame: 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
Time frame: 1 year
Dynamics of sensory changes
Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)
Time frame: 1 year
Dynamics of pain syndrome
Dynamics of pain syndrome based on numerical rating scale (NRS scale)
Time frame: 1 year
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