Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
Обзор
The advances in early detection coupled with improvements in treatments have led to an ever increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may complement the currently available treatment options. In particular, interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, and improve survival and the quality of life.This cross-sectional, prospective, observational study aims at evaluating dietary habits and nutritional knowledge in patients with early hormone receptor positive and hormone receptor negative breast cancer.
Подробное описание
The advances in early detection coupled with improvements in treatments have led to an ever increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may complement the currently available treatment options. In particular, interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, and improve survival and the quality of life.
The Women's Intervention Nutrition Study (WINS) and the Women's Healthy Eating and Living (WHEL) Randomized Trial examined the impact of dietary intervention on disease outcome in patients with early stage breast cancer, but with different results.
The Women's Intervention Nutrition Study randomized 2437 women with early stage breast cancer to receive a low-fat dietary intervention or usual care control and it demonstrated that dietary intervention improves disease free-survival of breast cancer patients receiving conventional cancer management. Although these benefit was no longer statistically significant at a longer follow-up, an exploratory subgroup analysis revealed that patients with hormone receptor-negative breast cancer continued to experience benefits from the intervention.
The Women's Healthy Eating and Living (WHEL) Randomized Trial, randomized 3088 women previously treated for early breast cancer, to receive low-fat, high-fruit, vegetable and fiber diet or to the control group. This trial failed to demonstrate a benefit in terms of recurrence rates within the experimental group.
Given the discrepancies among the findings of these two large trials, dietary changes are not routinely suggested as part of adjuvant therapies for breast cancer survivors and further research is needed to expand knowledge in this area. This study aims at evaluating dietary habits and nutritional knowledge in patients with early hormone receptor positive and hormone receptor negative breast cancer.
Первичные конечные точки
- Evaluation of nutritional knowledge in patients with surgically removed early breast cancer [Срок оценки: At baseline and at 3-5 years of follow up]
- Evaluation of dietary habits in patients with surgically removed early breast cancer [Срок оценки: At baseline and at 3-5 years of follow up]
- Evaluation of physical activity in patients with surgically removed early breast cancer [Срок оценки: At baseline and at 3-5 years of follow up]
Вторичные конечные точки (9)
- Association between nutritional knowledge and physical activity [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between nutritional knowledge and dietary habits [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between dietary habits and physical activity [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between dietary habits and BMI [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between dietary habits and waist to hip ratio [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between dietary habits and anthropometric measure [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between dietary habits and blood tests results [Срок оценки: At baseline and at 3-5 years of follow up]
- Association between dietary habits and disease relapse [Срок оценки: From baseline up to 5 years of follow up]
- Association between dietary habits and overall survival [Срок оценки: From baseline up to 5 years of follow up]
Критерии участия
Критерии включения
- Patients with surgically removed early stage (I-IIIa) hormone receptor-positive or hormone receptor negative breast cancer. Patients with hormone receptor-positive breast cancer can be in treatment with endocrine therapy; patients with hormone receptor-negative tumors have to be in follow-up. Concomitant use of targeted therapies with anti-hormonal agents is allowed only in adjuvant setting
- Female patients ≥18 years of age.
- Written informed consent must be obtained before any study-related assessment is performed
Критерии исключения
- Patients with advanced/metastatic breast cancer.
- Patients with early breast cancer receiving (neo)adjuvant chemotherapy or anti-HER2 agents
- Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano — Aviano
Идентификаторы
NCT: NCT06073418 · CRO-2022-30