Individualization of Nutritive Sensory Support Of Radiation Therapy

NCT ID: NCT05046028

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-12-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Test

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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)

Prospective Control group

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.

Group Type: ACTIVE_COMPARATOR

ONS without a sensor component and taste + standard diet

Intervention Type: DIETARY_SUPPLEMENT

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)

Retrospective Control group

60 patients who received chemoradiotherapy earlier with standard nutritional support.

Group Type: SHAM_COMPARATOR

Standard diet

Intervention Type: DIETARY_SUPPLEMENT

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).

Interventions

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)

Intervention Type: 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)

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• 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

Exclusion Criteria

• Simultaneous participation in another clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Gevorkov Artem R

senior researcher, radiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

P. Hertsen Moscow Oncology Research Institute

Moscow, , Russia

Countries

Russia

Other Identifiers

INSSORT

Identifier Type: -

Identifier Source: org_study_id