NCT05046028

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Radiotherapy; Complications
• Head and Neck Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet	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)
DIETARY_SUPPLEMENT	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)
DIETARY_SUPPLEMENT	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).

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-05-15
• Completion: 2022-12-15
• First posted: 2021-09-16
• Last updated: 2023-03-24

Locations

1 site across 1 country: Russia