Clinical trial NCT06073418: Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients
Official title: Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 1098
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with early stage hormone receptor positive breast cancer treated at the Department of Medical Oncology and Cancer Prevention, IRCCS National Cancer Institute of Aviano and at the other involved clinical centers considered eligible for the study will be enrolled, after providing written informed consent.

Brief summary: 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.

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)

Primary outcomes:
measure: Evaluation of nutritional knowledge in patients with surgically removed early breast cancer
timeFrame: At baseline and at 3-5 years of follow up
measure: Evaluation of dietary habits in patients with surgically removed early breast cancer
timeFrame: At baseline and at 3-5 years of follow up
measure: Evaluation of physical activity in patients with surgically removed early breast cancer
timeFrame: At baseline and at 3-5 years of follow up
Secondary outcomes:
measure: Association between nutritional knowledge and physical activity
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between nutritional knowledge and dietary habits
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between dietary habits and physical activity
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between dietary habits and BMI
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between dietary habits and waist to hip ratio
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between dietary habits and anthropometric measure
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between dietary habits and blood tests results
timeFrame: At baseline and at 3-5 years of follow up
measure: Association between dietary habits and disease relapse
timeFrame: From baseline up to 5 years of follow up
measure: Association between dietary habits and overall survival
timeFrame: From baseline up to 5 years of follow up
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
state: Pordonone
Study officials:
affiliation: IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
name: Mattia Garutti, MD
role: PRINCIPAL_INVESTIGATOR
References: