Individualization of Nutritive Sensory Support Of Radiation Therapy

NCT05046028 | Completed Phase 4

• 1 other identifier: INSSORT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Nutritional support; Radiotherapy; Head and Neck Cancer; Complications

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Tolerance to chemoradiation therapy - mucositis

  4 months

• Tolerance to chemoradiation therapy - dermatitis

  4 months

• Terms of treatment

  during radiation treatment

• Unplanned breaks

  during radiation treatment

• Efficiency of chemoradiation therapy

  1 year

Study Arms (3)

Test

EXPERIMENTAL

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

Prospective Control group

ACTIVE COMPARATOR

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

Retrospective Control group

SHAM COMPARATOR

60 patients who received chemoradiotherapy earlier with standard nutritional support.

Dietary Supplement: Standard diet

Interventions

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

Test

ONS without a sensor component and taste + standard diet 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)

Prospective Control group

Standard diet 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).

Retrospective Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Simultaneous participation in another clinical trial
• 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

Sponsors & Collaborators

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

Study Sites (1)

P. Hertsen Moscow Oncology Research Institute

Moscow, 125284, Russia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Dietary Supplements; Taste

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior researcher, radiotherapist

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: September 16, 2021
• Study Start: December 15, 2020
• Primary Completion: May 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

RU (1)