Effect of a Clinical Nutrition Intervention Program in Breast Cancer Patients During Antineoplastic Treatment
Ключови думи
Резюме
Дати
Последна проверка: | 07/31/2018 |
Първо изпратено: | 08/07/2018 |
Очаквано записване подадено: | 08/08/2018 |
Първо публикувано: | 08/09/2018 |
Изпратена последна актуализация: | 08/08/2018 |
Последна актуализация публикувана: | 08/09/2018 |
Действителна начална дата на проучването: | 09/13/2015 |
Приблизителна дата на първично завършване: | 08/31/2018 |
Очаквана дата на завършване на проучването: | 07/31/2019 |
Състояние или заболяване
Интервенция / лечение
Other: Nutrition diagnosis and intervention
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Experimental: Nutrition diagnosis and intervention At baseline and 6-mo after, a nutrition diagnosis will be done by measuring body composition components with DXA and basic anthropometric measurements. Based on the results, an individualized food-based intervention will be prescribed for each patient according to her diagnosis, food preferences, cultural and socioeconomic status. Follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed and initial measurements are repeated. | Other: Nutrition diagnosis and intervention Diet plans and recommendations will be based on the individual's nutritional status, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein and when required, a caloric restriction (500-1000 kcal/d). Garlic and cruciferous vegetables will be encouraged as well as 5-9 servings of fruits and vegetables a day. The program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed. |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | Female |
Приема здрави доброволци | Да |
Критерии | Inclusion Criteria: - nonmetastatic breast cancer patient - before antineoplastic treatment initiation Exclusion Criteria: - bone fracture(s) - disease(s) that could affect body composition (i.e. hypothyroidism) - disease(s) that would require an additional dietary therapeutic approach or consideration (i.e. diabetes) - dietary supplement consumption - body dimensions surpassed the equipment's capacity Elimination Criteria: - newly diagnosed disease(s) that could affect body composition (i.e. hypothyroidism) - newly diagnosed disease(s) that would require an additional dietary therapeutic approach or consideration (i.e. diabetes) - dietary supplement consumption during the intervention - patient's decision to refuse or stop antineoplastic treatment - patient's decision to quit the intervention |
Резултат
Първични изходни мерки
1. Total body weight [baseline and after the 6-mo food-based intervention]
Вторични изходни мерки
1. Body fat mass [baseline and after the 6-mo food-based intervention]
2. Body fat-free mass [baseline and after the 6-mo food-based intervention]
3. Skeletal muscle mass [baseline and after the 6-mo food-based intervention]
4. Waist circumference [baseline and after the 6-mo food-based intervention]
5. Retinol [baseline and after the 6-mo food-based intervention]
6. Trolox-equivalent antioxidant capacity test [baseline and after the 6-mo food-based intervention]
7. Glutathione peroxidase (GPx) [baseline and after the 6-mo food-based intervention]
8. Superoxide dismutase (SOD) [baseline and after the 6-mo food-based intervention]
9. Human inflammatory cytokines [baseline and after the 6-mo food-based intervention]