Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)

Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 1098

Contacts and Locations

• Study Contact: Name: Giulia Cudia, MSc; Email: giulia.cudia@cro.it
• Study Contact Backup: Name: Mattia Garutti, MD; Phone Number: 0434 659092; Email: mattia.garutti@cro.it

Study Locations

• Italy
  • Pordonone
    • Aviano, Pordonone, Italy, 33081
      • Recruiting
      • IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
      • Contact: Giulia Cudia, MSc; Email: giulia.cudia@cro.it
      • Contact: Mattia Garutti, MD; Phone Number: 0434 659092; Email: mattia.garutti@cro.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano
• Investigators: Principal Investigator: Mattia Garutti, MD, IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Estimated): July 1, 2032
• Study Completion (Estimated): July 1, 2032

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CRO-2022-30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No