Individualization of Nutritive Sensory Support Of Radiation Therapy

Phase 4

Completed

• Conditions: Radiotherapy; Complications; Head and Neck Cancer
• Interventions: Dietary Supplement: Standard diet; Dietary Supplement: ONS without a sensor component and taste + standard diet; Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet

• Registration Number: NCT05046028
• Lead Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-15
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Primary Completion: 2022-05-15
• Study Completion: 2022-12-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retrospective Control group	Standard diet	60 patients who received chemoradiotherapy earlier with standard nutritional support.
Prospective Control group	ONS without a sensor component and taste + standard diet	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.
Test	Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Unplanned breaks	during radiation treatment	Days of delayed treatment
Terms of treatment	during radiation treatment	Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one.
Efficiency of chemoradiation therapy	1 year	Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
1-year locoregional control	1 year	1-year locoregional control after chemoradiation therapy
1-year overall survival	1 year	1-year overall survival is the percentage of people who are alive one year after they started chemoradiation therapy
Tolerance to chemoradiation therapy - mucositis	4 months	Mucositis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Tolerance to chemoradiation therapy - dermatitis	4 months	Dermatitis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
1-year relapse-free survival	1 year	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	1 year	Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)
Dynamics of pain syndrome	1 year	Dynamics of pain syndrome based on numerical rating scale (NRS scale)

Trial Locations

Locations (1)

P. Hertsen Moscow Oncology Research Institute; 🇷🇺 Moscow, Russian Federation