IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, 33081, Italy
Location status: Recruiting
Location contact
Giulia Cudia, MSc
CONTACT
Mattia Garutti, MD
CONTACT
NCT Number: NCT06073418
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Aviano, Pordonone, 33081, Italy
Location status: Recruiting
Giulia Cudia, MSc
CONTACT
Mattia Garutti, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline and at 3-5 years of follow up
Median and interquartile range of items of nutritional knowledge questionnaire in patients with surgically removed early breast cancer
Time frame: At baseline and at 3-5 years of follow up
Frequency of different answers at dietary habits questionnaire
Time frame: At baseline and at 3-5 years of follow up
Frequency of different answers at activity questionnaire
Time frame: At baseline and at 3-5 years of follow up
difference in nutritional knowledge score between subgroups of patients with different levels of physical activity
Time frame: At baseline and at 3-5 years of follow up
difference in nutritional knowledge score between subgroups of patients with different frequencies of consumption for selected foods
Time frame: At baseline and at 3-5 years of follow up
association between frequencies of consumption for selected foods and levels of physical activity
Time frame: At baseline and at 3-5 years of follow up
Difference in frequencies of consumption for selected foods between BMI categories
Time frame: At baseline and at 3-5 years of follow up
Difference in mean of waist to hip ratio between subgroups of patients with different frequencies of consumption for selected foods
Time frame: At baseline and at 3-5 years of follow up
Difference in mean of waist, hip, abdomen circumferences between subgroups of patients with different frequencies of consumption for selected foods
Time frame: At baseline and at 3-5 years of follow up
Differences in mean level of selected blood test (e.i glycemia, HDL, LDL) between subgroups of patients with different frequencies of consumption for selected foods
Time frame: From baseline up to 5 years of follow up
Association between answers to dietary habits questionnaire and progression free survival defined as the time from study enrolment until progression or death from any cause whichever comes first
Time frame: From baseline up to 5 years of follow up
Association between answers to dietary habits questionnaire and overall survival defined as the time from study enrolment until death from any cause
Contact information is provided by the study sponsor or research team.
Giulia Cudia, MSc
CONTACT
Mattia Garutti, MD
CONTACT
Centro di Riferimento Oncologico - Aviano
Other
Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
Acronym: DEMETRA
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