Breast Cancer Clinical Trial
— DEMETRAOfficial title:
Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
NCT number | NCT06073418 |
Other study ID # | CRO-2022-30 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 28, 2022 |
Est. completion date | July 1, 2032 |
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.
Status | Recruiting |
Enrollment | 1098 |
Est. completion date | July 1, 2032 |
Est. primary completion date | July 1, 2032 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano | Aviano | Pordonone |
Lead Sponsor | Collaborator |
---|---|
Centro di Riferimento Oncologico - Aviano |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of nutritional knowledge in patients with surgically removed early breast cancer | Median and interquartile range of items of nutritional knowledge questionnaire in patients with surgically removed early breast cancer | At baseline and at 3-5 years of follow up | |
Primary | Evaluation of dietary habits in patients with surgically removed early breast cancer | Frequency of different answers at dietary habits questionnaire | At baseline and at 3-5 years of follow up | |
Primary | Evaluation of physical activity in patients with surgically removed early breast cancer | Frequency of different answers at activity questionnaire | At baseline and at 3-5 years of follow up | |
Secondary | Association between nutritional knowledge and physical activity | difference in nutritional knowledge score between subgroups of patients with different levels of physical activity | At baseline and at 3-5 years of follow up | |
Secondary | Association between nutritional knowledge and dietary habits | difference in nutritional knowledge score between subgroups of patients with different frequencies of consumption for selected foods | At baseline and at 3-5 years of follow up | |
Secondary | Association between dietary habits and physical activity | association between frequencies of consumption for selected foods and levels of physical activity | At baseline and at 3-5 years of follow up | |
Secondary | Association between dietary habits and BMI | Difference in frequencies of consumption for selected foods between BMI categories | At baseline and at 3-5 years of follow up | |
Secondary | Association between dietary habits and waist to hip ratio | Difference in mean of waist to hip ratio between subgroups of patients with different frequencies of consumption for selected foods | At baseline and at 3-5 years of follow up | |
Secondary | Association between dietary habits and anthropometric measure | Difference in mean of waist, hip, abdomen circumferences between subgroups of patients with different frequencies of consumption for selected foods | At baseline and at 3-5 years of follow up | |
Secondary | Association between dietary habits and blood tests results | 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 | At baseline and at 3-5 years of follow up | |
Secondary | Association between dietary habits and disease relapse | 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 | From baseline up to 5 years of follow up | |
Secondary | Association between dietary habits and overall survival | Association between answers to dietary habits questionnaire and overall survival defined as the time from study enrolment until death from any cause | From baseline up to 5 years of follow up |
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