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Идёт набор NCT06385691

Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.

Фаза II С лечением Gastric Cancer Oesogastric Junction 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: myDIET software tool.
Кому может быть актуально
Состояния в реестре: Gastric Cancer, Oesogastric Junction Cancer. Базовые параметры: от 18 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 →
Официальное название

Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.

Обзор

This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer.

Подробное описание

Gastric cancer is the 3rd leading cause of cancer mortality worldwide, with a 5-year survival rate of less than 30%. In localised gastric cancer (GC) or cancer of the oesogastric junction (OGJ), the standard treatment consists of gastrectomy and peri-operative FLOT-based chemotherapy (5FU, Leucovorin, Oxaliplatin, Taxotere). However, up to 51% of patients have post-operative complications, and only 60% can benefit from post-operative chemotherapy (at least one course) initiated within 12 weeks of surgery, while 46% receive the full theoretical regimen.

An incomplete adjuvant chemotherapy regimen drastically reduces post-operative prognosis. Undernutrition and sarcopenia increase the occurrence of post-operative complications, length of stay and post-operative readmissions. Undernutrition is an independent risk factor for failure and/or incomplete adjuvant chemotherapy, with an impact on progression-free survival and overall survival. There is a high prevalence of undernutrition in patients with GC/OGJ, estimated at 53-60%, and the proportion of undernourished patients increases significantly postoperatively compared with preoperatively.

Preoperative nutrition and physical activity in sarcopenic patients has been shown to reduce postoperative complications. Early multimodal management, combining nutrition, adapted physical activity and neoadjuvant chemotherapy, is therefore recommended and essential in the perioperative situation. To optimise the nutritional management of patients with operable gastric or oesogastric junction cancer, the CLB teams have developed a computer interface (MyDIET) linked to the myCLB patient portal. This provides semi-personalised monitoring based on self-questionnaires designed to assess and educate patients or their carers about nutritional issues from the outset of oncology treatment, and to prevent the onset or worsening of undernutrition.

For this reason, the sponsor proposes an exploratory study to assess the efficacy of the myDIET digital tool in increasing the proportion of patients with localised CG/OGJ initially treated with neo-adjuvant chemotherapy and who undergo surgery and are able to receive adjuvant chemotherapy within 8 weeks post-operatively.

Вмешательства

  • Другое myDIET software tool
    The tool is based on self-questionnaires completed by the patient. They are mainly filled in using visual analogue scales (from 0-10) or grades of symptoms/toxicities (Grades 0 to 4), based on the CTCAE V5. These scales will cover the following themes: food intake, weight changes, digestive symptoms, taste disorders, pain and fatigue. The system will be able to monitor data changes and the response given will be adapted according to the severity of symptoms: * No signs of seriousness: general p

Первичные конечные точки

  • Proportion of patients starting adjuvant treatment within 2 months [Срок оценки: 2 months after surgery]
Вторичные конечные точки (12)
  • Adherence to the tool [Срок оценки: From inclusion and up to 6 months after surgery]
  • Number of supportive care and emergency consultations initiated by the caregiver [Срок оценки: From inclusion and up to 6 months after surgery]
  • Proportion of patients with malnutrition [Срок оценки: From inclusion and up to 6 months after surgery]
  • Evolution of body composition in L3 section (volumes) [Срок оценки: From inclusion and up to 6 months after surgery]
  • Evolution of body composition in L3 section (indexes) [Срок оценки: From inclusion and up to 6 months after surgery]
  • Evolution of resting energy expenditure [Срок оценки: From inclusion and up to 1 month after surgery]
  • Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day [Срок оценки: From inclusion and up to 6 months after surgery]
  • Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry [Срок оценки: From inclusion and up to 6 months after surgery]
  • Weight changes [Срок оценки: From inclusion and up to 6 months after surgery]
  • Brachial circumference changes [Срок оценки: From inclusion and up to 6 months after surgery]
  • Triceps skin fold changes [Срок оценки: From inclusion and up to 6 months after surgery]
  • Initiation time for post-operative treatment [Срок оценки: From surgery to date of post operative treatment initiation assessed up to 6 months after surgery]

Критерии участия

Критерии включения

  • Patient 18 years of age or older at date of signing informed consent to participate;
  • Histologically proven diagnosis of gastric adenocarcinoma or OGJ;
  • Localized, resectable disease;
  • Patients with an indication for perioperative chemotherapy and/or immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;
  • Performance status (ECOG): 0-2;
  • Membership of a social security scheme;
  • Signed informed consent to participate.

Критерии исключения

  • Other associated solid cancer or haemopathy;
  • Presence of severe comorbidity (Charlson index > 9)
  • Presence of unbalanced dysthyroidism;
  • History of gastric, duodenal or esophageal surgery;
  • Inability to comply with study requirements, including :
  • Impossibility for the patient or his/her caregiver to connect to myDIET;
  • Difficulty in understanding the written French language;
  • Psychological incapacity (e.g. excessive vulnerability, psychiatric disorder) or physical incapacity (e.g. physical/motor disability);
  • Patient under guardianship, curatorship or safeguard of justice;
  • Patients already participating in a clinical trial or interventional study likely to interfere with the evaluation of the primary endpoint.
  • Pregnant or breast-feeding patient.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Франция · 1 центр
  • Centre Léon Berard — Lyon

Идентификаторы

NCT: NCT06385691 · ET22-145

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗