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

NCT ID: NCT06073418

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1098 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2032-07-01

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mattia Garutti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)

Locations

IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordonone, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mattia Garutti, MD

Role: CONTACT

mattia.garutti@cro.it

0434 659092

Giulia Cudia, MSc

Role: CONTACT

giulia.cudia@cro.it

Facility Contacts

Mattia Garutti, MD

Role: primary

mattia.garutti@cro.it

0434 659092

Giulia Cudia, MSc

Role: backup

giulia.cudia@cro.it

Other Identifiers

CRO-2022-30

Identifier Type: -

Identifier Source: org_study_id