Skip to main content
OpenTrials
Completed

NCT Number: NCT05046028

Individualization of Nutritive Sensory Support Of Radiation Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiotherapy; Complications Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

P. Hertsen Moscow Oncology Research Institute

Moscow, 125284, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

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).

Primary outcomes

  1. Quality of life (QoL)

    Time frame: 1 year

    QoL is evaluated and recorded according to questionnaire The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

  2. Nutritional status

    Time frame: 1 year

    Nutritional status is evaluated and recorded according to Nutritional Risk Screening (NRS) 2002

  3. Patient compliance

    Time frame: 1 year

    The level of patient compliance is evaluated and recorded according to Morisky 8-Item Medication Adherence Questionnaire.

Secondary outcomes

  1. Tolerance to chemoradiation therapy - mucositis

    Time frame: 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

  2. Tolerance to chemoradiation therapy - dermatitis

    Time frame: 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

  3. Terms of treatment

    Time frame: during radiation treatment

    Terms of treatment is recorded in total number of days from the first day of radiation treatment to the last one.

  4. Unplanned breaks

    Time frame: during radiation treatment

    Days of delayed treatment

  5. Efficiency of chemoradiation therapy

    Time frame: 1 year

    Degree of tumor resorption by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

  6. 1-year locoregional control

    Time frame: 1 year

    1-year locoregional control after chemoradiation therapy

  7. 1-year overall survival

    Time frame: 1 year

    1-year overall survival is the percentage of people who are alive one year after they started chemoradiation therapy

  8. 1-year relapse-free survival

    Time frame: 1 year

    1-year relapse-free survival is the percentage of people who have not had relaps one year after they started chemoradiation therapy

  9. Dynamics of sensory changes

    Time frame: 1 year

    Dynamics of sensory changes based on the adapted total soluble solids scale (TSS scale)

  10. Dynamics of pain syndrome

    Time frame: 1 year

    Dynamics of pain syndrome based on numerical rating scale (NRS scale)

Sponsors and collaborators

Lead sponsor

National Medical Research Radiological Centre of the Ministry of Health of Russia

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.