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Набор скоро начнётся NCT06803381

Somesthesia in Cancer Patients: Variability and Influence on Eating Experience

— Наблюдательное Digestive Cancers Breast Cancer Gynecologic Cancer Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Salivary test, Food tasting, Questionnaires, sensory capacity evaluation.
Кому может быть актуально
Состояния в реестре: Digestive Cancers, Breast Cancer, Gynecologic Cancer, Lung Cancer. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Patients with cancer are at high risk of denutrition, in France 39% of these patients suffer of malnutrition. This can affect the immunity, the mental balance and impact the treatment response and the quality of life. Cancer treatments cause many side effects related to food intake as well as sensory alteration, important factor contributing to reduced appetite and inadequate food intake to cancer patients. SOMEST'ALIM2 is a prospective, non-randomized, monocentric, multisite study that aims to evaluate the appreciation of patients with different types of cancer (digestive, gynecological, breast, ear, nose and throat (ENT) or lung) of two different food versions (sweet and salty), in standard and enhanced version. Patients must be under treatment from at least two months, and before food testing their sensory capacity and quantity and the quality of their saliva will be tested. They will also be asked to answer to different questionnaires: socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, MD, Quality of Life Questionnaire (QLQ-C30) and food quality of life questionnaire. In a context of sensory alterations patients should appreciate more the enhanced food versions. Patients perception of food will be evaluated using a visual analogue scale and results will be correlated with saliva characteristics, subjective sensory perceptions and oral symptoms.

Вмешательства

  • Другое Salivary test
    In order to determine the quantity and quality of patients saliva before food tasting a saliva test will be performed using a Saliva-Check BUFFER kit. A small quantity of saliva will be collected and discarded immediately after the test result obtained. The test will be done only once for each patient.
  • Другое Food tasting
    Patients will be invited to taste four different food samples, 2 sweet and 2 salty samples, and to evaluate them using a visual analog scale (0 : I don't like at all to 100 : I like a lot). The intervention will be done once for each patient during one of their standard of care treatment visit.
  • Другое Questionnaires
    Patients will be invited to answer to some questionnaires : socio-demographics, appreciation of food samples, self-assessment of oral symptoms and sensory perceptions, QLQ-C30 quality of life and food quality of life questionnaire. They will answer to all questionnaires only once during participation to the study.
  • Другое sensory capacity evaluation
    For the sensory capacity the test 6-n-propylthiouracil (PROP) taste strip will be used. One tasting strip will be placed on the tongue and patients will be asked to assess the intensity of bitterness. The test will be done only once for each patient.

Первичные конечные точки

  • visual analogue scale (VAS) score [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Patient between 18 and 70 years old
  • Patient with digestive, breast, gynecologic, ENT or lung cancer
  • Patient receiving a cancer treatment from at least two months
  • Patient having given his free, informed and express written consent

Критерии исключения

  • Patient having a radiotherapy treatment for an ENT cancer
  • Patient with a known food allergy/intolerance to food samples (which may contain dairy products)
  • Patient unable to swallow soft food
  • Patient having presented nausea and vomiting during the last 24 hours
  • Patient with severe inflammation of the mouth or throat (ulcers, mucus)
  • Patient with cognitive disorders and memory loss
  • Pregnant women or breastfeeding
  • Adult under legal protection (guardianship)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 2 центра
  • Service d'Oncologie Médicale - Hôpital de jour Hôpital Edouard Herriot — Lyon
  • Service d'Oncologie Médicale - Hôpital de jour Hôpital de la Croix Rousse — Lyon

Идентификаторы

NCT: NCT06803381 · 69HCL24_0539 · 2024-A02687-40

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗