Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
Overview
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.
Detailed description
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.
Primary outcome measures
- Evaluation of nutritional knowledge in patients with surgically removed early breast cancer [Time frame: At baseline and at 3-5 years of follow up]
- Evaluation of dietary habits in patients with surgically removed early breast cancer [Time frame: At baseline and at 3-5 years of follow up]
- Evaluation of physical activity in patients with surgically removed early breast cancer [Time frame: At baseline and at 3-5 years of follow up]
Secondary outcome measures (9)
- Association between nutritional knowledge and physical activity [Time frame: At baseline and at 3-5 years of follow up]
- Association between nutritional knowledge and dietary habits [Time frame: At baseline and at 3-5 years of follow up]
- Association between dietary habits and physical activity [Time frame: At baseline and at 3-5 years of follow up]
- Association between dietary habits and BMI [Time frame: At baseline and at 3-5 years of follow up]
- Association between dietary habits and waist to hip ratio [Time frame: At baseline and at 3-5 years of follow up]
- Association between dietary habits and anthropometric measure [Time frame: At baseline and at 3-5 years of follow up]
- Association between dietary habits and blood tests results [Time frame: At baseline and at 3-5 years of follow up]
- Association between dietary habits and disease relapse [Time frame: From baseline up to 5 years of follow up]
- Association between dietary habits and overall survival [Time frame: From baseline up to 5 years of follow up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano — Aviano
Identifiers
NCT: NCT06073418 · CRO-2022-30