Individualization of Nutritive Sensory Support Of Radiation Therapy

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

Status and phase: Completed; Phase 4

Conditions: Radiotherapy; Complications; Head and Neck Cancer

Treatments: Dietary Supplement: ONS without a sensor component and taste + standard diet; Dietary Supplement: Standard diet; Dietary Supplement: Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05046028

INSSORT

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Test

Experimental group

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.

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 group

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.

Treatment:

Dietary Supplement: ONS without a sensor component and taste + standard diet

Retrospective Control group

Sham Comparator group

Description:

60 patients who received chemoradiotherapy earlier with standard nutritional support.

Treatment:

Dietary Supplement: Standard diet