Neoplasms

All Conditions

Head and Neck Neoplasms

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.

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.

60 patients who received chemoradiotherapy earlier with standard nutritional support.

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)

Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet

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)

ONS without a sensor component and taste + standard diet

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).

Standard diet

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.

Individualization of Nutritive Sensory Support Of Radiation Therapy

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

QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002

The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.

Mucositis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Dermatitis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one.

Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

1-year locoregional control after chemoradiation therapy

1-year overall survival is the percentage of people who are alive one year after they started chemoradiation therapy

1-year relapse-free survival is the percentage of people who have not had relaps one year after they started chemoradiation therapy

Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)

Dynamics of pain syndrome based on numerical rating scale (NRS scale)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Individualization of Nutritive Sensory Support Of Radiation Therapy	NCT05046028	Radiotherapy; C... Head and Neck C...	Oral nutritiona... ONS without a s... Standard diet	18 Years -	National Medical Research Radiological Centre of the Ministry of Health of Russia
Individualization of Nutritive Sensory Support Of Radiation Therapy	NCT05046028	Radiotherapy; C... Head and Neck C...	Oral nutritiona... ONS without a s... Standard diet	18 Years -	National Medical Research Radiological Centre of the Ministry of Health of Russia

Spots Global Cancer Trial Database for oral nutritional supplements (ons) with a cooling effect + ons without a sensor component and taste + standard diet