Individualization of Nutritive Sensory Support Of Radiation Therapy

PHASE4CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

May 15, 2022

Study Completion Date

December 15, 2022

Conditions
Radiotherapy; ComplicationsHead and Neck Cancer
Interventions
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).

Trial Locations (1)

125284

P. Hertsen Moscow Oncology Research Institute, Moscow

All Listed Sponsors
lead

National Medical Research Radiological Centre of the Ministry of Health of Russia

OTHER

NCT05046028 - Individualization of Nutritive Sensory Support Of Radiation Therapy | Biotech Hunter | Biotech Hunter