Individualization of Nutritive Sensory Support Of Radiation Therapy

Head and Neck Cancer Clinical Trial

Official title:

Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046028
• Other study ID #: INSSORT
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: National Medical Research Radiological Centre of the Ministry of Health of Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiotherapy; Complications

Intervention

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 (? 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)
• 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)
• 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).

Locations

Country	Name	City	State
Russian Federation	P. Hertsen Moscow Oncology Research Institute	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Radiological Centre of the Ministry of Health of Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life (QoL)	QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)	1 year
Primary	Nutritional status	Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002	1 year
Primary	Patient compliance	The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Unplanned breaks	Days of delayed treatment	during radiation treatment
Secondary	Efficiency of chemoradiation therapy	Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).	1 year
Secondary	1-year locoregional control	1-year locoregional control after chemoradiation therapy	1 year
Secondary	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
Secondary	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
Secondary	Dynamics of sensory changes	Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)	1 year
Secondary	Dynamics of pain syndrome	Dynamics of pain syndrome based on numerical rating scale (NRS scale)	1 year