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

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 Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Radiotherapy; Complications
• Intervention / Treatment: Dietary supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet; Dietary supplement: ONS without a sensor component and taste + standard diet; Dietary supplement: Standard diet

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mariia Sedova; Phone Number: +79253093463; Email: mariya.sedova58@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 125284
    • P. Hertsen Moscow Oncology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

• Simultaneous participation in another clinical trial
• Failure to meet inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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)
Active Comparator: 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.	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)
Sham Comparator: Retrospective Control group; 60 patients who received chemoradiotherapy earlier with standard nutritional support.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QoL)	QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)	1 year
Nutritional status	Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002	1 year
Patient compliance	The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	during radiation treatment
Unplanned breaks	Days of delayed treatment	during radiation treatment
Efficiency of chemoradiation therapy	Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).	1 year
1-year locoregional control	1-year locoregional control after chemoradiation therapy	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	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	1 year
Dynamics of sensory changes	Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)	1 year
Dynamics of pain syndrome	Dynamics of pain syndrome based on numerical rating scale (NRS scale)	1 year

Collaborators and Investigators

• Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): May 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Radiotherapy; Complications; Nutritional support
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: INSSORT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No