Clinical trial NCT05046028: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radiotherapy; Complications
Head and Neck Cancer
Keywords: Nutritional support
Radiotherapy
Head and Neck Cancer
Complications
Lead sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: 1 year
measure: Nutritional status
timeFrame: 1 year
measure: Patient compliance
timeFrame: 1 year
Secondary outcomes:
measure: Tolerance to chemoradiation therapy - mucositis
timeFrame: 4 months
measure: Tolerance to chemoradiation therapy - dermatitis
timeFrame: 4 months
measure: Terms of treatment
timeFrame: during radiation treatment
measure: Unplanned breaks
timeFrame: during radiation treatment
measure: Efficiency of chemoradiation therapy
timeFrame: 1 year
measure: 1-year locoregional control
timeFrame: 1 year
measure: 1-year overall survival
timeFrame: 1 year
measure: 1-year relapse-free survival
timeFrame: 1 year
measure: Dynamics of sensory changes
timeFrame: 1 year
measure: Dynamics of pain syndrome
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: P. Hertsen Moscow Oncology Research Institute
Study officials:
References: