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Individualization of Nutritive Sensory Support Of Radiation Therapy

Primary Purpose

Radiotherapy; Complications, Head and Neck Cancer

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet
ONS without a sensor component and taste + standard diet
Standard diet
Sponsored by
National Medical Research Radiological Centre of the Ministry of Health of Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Radiotherapy; Complications focused on measuring Nutritional support, Radiotherapy, Head and Neck Cancer, Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • P. Hertsen Moscow Oncology Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Test

Prospective Control group

Retrospective Control group

Arm Description

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.

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.

60 patients who received chemoradiotherapy earlier with standard nutritional support.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Terms of treatment
Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one.
Unplanned breaks
Days of delayed treatment
Efficiency of chemoradiation therapy
Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
1-year locoregional control
1-year locoregional control after chemoradiation therapy
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 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
Dynamics of sensory changes
Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)
Dynamics of pain syndrome
Dynamics of pain syndrome based on numerical rating scale (NRS scale)

Full Information

First Posted
June 2, 2021
Last Updated
March 23, 2023
Sponsor
National Medical Research Radiological Centre of the Ministry of Health of Russia
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1. Study Identification

Unique Protocol Identification Number
NCT05046028
Brief Title
Individualization of Nutritive Sensory Support Of Radiation Therapy
Official Title
Individual Nutritional Support With High Protein Formula With Modified Sensory Component for H&N Cancer Patients on Chemo and Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Medical Research Radiological Centre of the Ministry of Health of Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy; Complications, Head and Neck Cancer
Keywords
Nutritional support, Radiotherapy, Head and Neck Cancer, Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
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.
Arm Title
Prospective Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Retrospective Control group
Arm Type
Sham Comparator
Arm Description
60 patients who received chemoradiotherapy earlier with standard nutritional support.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet
Intervention Description
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
Intervention Name(s)
ONS without a sensor component and taste + standard diet
Intervention Description
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
Intervention Name(s)
Standard diet
Intervention Description
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).
Primary Outcome Measure Information:
Title
Quality of life (QoL)
Description
QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Time Frame
1 year
Title
Nutritional status
Description
Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002
Time Frame
1 year
Title
Patient compliance
Description
The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Tolerance to chemoradiation therapy - mucositis
Description
Mucositis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time Frame
4 months
Title
Tolerance to chemoradiation therapy - dermatitis
Description
Dermatitis as adverse event of chemoradiation therapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Time Frame
4 months
Title
Terms of treatment
Description
Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one.
Time Frame
during radiation treatment
Title
Unplanned breaks
Description
Days of delayed treatment
Time Frame
during radiation treatment
Title
Efficiency of chemoradiation therapy
Description
Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Time Frame
1 year
Title
1-year locoregional control
Description
1-year locoregional control after chemoradiation therapy
Time Frame
1 year
Title
1-year overall survival
Description
1-year overall survival is the percentage of people who are alive one year after they started chemoradiation therapy
Time Frame
1 year
Title
1-year relapse-free survival
Description
1-year relapse-free survival is the percentage of people who have not had relaps one year after they started chemoradiation therapy
Time Frame
1 year
Title
Dynamics of sensory changes
Description
Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)
Time Frame
1 year
Title
Dynamics of pain syndrome
Description
Dynamics of pain syndrome based on numerical rating scale (NRS scale)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Facility Information:
Facility Name
P. Hertsen Moscow Oncology Research Institute
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation

12. IPD Sharing Statement

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Individualization of Nutritive Sensory Support Of Radiation Therapy

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