Assessing Diet, Nutrition Knowledge, and Physical Activity in Early Stage Breast Cancer Patients
Official title: Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
Run by Centro di Riferimento Oncologico - Aviano · NCT06073418 · Data updated 2026-11-12
This study looks at how diet, nutrition knowledge, and physical activity affect women with early stage breast cancer to see if these factors can help improve their quality of life and reduce the chance of cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1098 (estimated) |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aviano, Pordonone) |
| Status | Recruiting |
| Started | October 28, 2022 |
| Main results expected | July 1, 2032 |
| Study ends | July 1, 2032 |
| Registry record updated | October 10, 2023 |
| Trial ID | NCT06073418 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 18 and older with early stage hormone receptor-positive or hormone receptor-negative breast cancer who have undergone surgical treatment.
✕Probably not a fit
Patients with advanced or metastatic breast cancer or those currently receiving active treatment for secondary tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the dietary habits and nutritional knowledge of female patients with early stage breast cancer, both hormone receptor-positive and hormone receptor-negative. It aims to identify how diet and physical activity can influence cancer recurrence and improve quality of life among survivors. The study builds on previous research that explored dietary interventions and their effects on disease outcomes in breast cancer patients. By gathering data on lifestyle factors, the study seeks to inform future interventions that could enhance patient care.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life and reduced risk of cancer recurrence for breast cancer survivors.
How similar studies have gone: Previous studies like the Women's Intervention Nutrition Study have shown that dietary interventions can improve disease-free survival in early stage breast cancer patients, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, Italy Recruiting
Study contacts
- Principal investigator: Mattia Garutti, MD — IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
- Study coordinator: Mattia Garutti, MD
- Email: mattia.garutti@cro.it
- Phone: 0434 659092
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.