Breast CancerDEMETRANCT06073418
Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients
An observational study of Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,098 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2022to 1 Jul 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Cudia, MSc contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS, Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordonone, 33081
Mattia Garutti, MD, 0434 659092, mattia.garutti@cro.it
Giulia Cudia, MSc, giulia.cudia@cro.it
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: At baseline and at 3-5 years of follow up
Secondary outcomes (9)
Association between nutritional knowledge and physical activity
difference in nutritional knowledge score between subgroups of patients with different levels of physical activity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline up to 5 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start28 Oct 2022
- Primary completion1 Jul 2032 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,098 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mattia Garutti, MD, Principal investigator, IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073418
- Sponsor's protocol ID
- CRO-2022-30
- Acronym
- DEMETRA
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Habits, Nutritional Knowledge and Physical Activity Assessment in Early Stage Breast Cancer Patients (DEMETRA)
- ClinicalTrials.gov ID
- NCT06073418
- Acronym / sponsor ID
- DEMETRA / CRO-2022-30
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,098 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 1 Jul 2032 (estimated)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of nutritional knowledge in patients with surgically removed early breast cancer
Time frame: At baseline and at 3-5 years of follow up
Median and interquartile range of items of nutritional knowledge questionnaire in patients with surgically removed early breast cancer
Evaluation of dietary habits in patients with surgically removed early breast cancer
Time frame: At baseline and at 3-5 years of follow up
Frequency of different answers at dietary habits questionnaire
Evaluation of physical activity in patients with surgically removed early breast cancer
Time frame: At baseline and at 3-5 years of follow up
Frequency of different answers at activity questionnaire
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulia Cudia, MSc contact
Mattia Garutti, MD principal investigator
IRCCS-Centro di Riferimento Oncologico (CRO), Aviano (PN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattia Garutti, MD (0434 659092, mattia.garutti@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of nutritional knowledge in patients with surgically removed early breast cancer (time frame: At baseline and at 3-5 years of follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.