The DAMA - Diet Exercise and Mammography (Dieta Attività fisica e MAmmografia) Trial: a physical activity and diet intervention trial to reduce mammographic breast density, a strong risk factor for breast cancer, in postmenopausal women

Conditions

Change in mammographic breast density Cancer

Benedetta Bendinelli, Giovanna Danza, Melania Assedi, Fabio Villanelli, Giulia Vagnoni et al. (12 authors)

American Journal of Clinical Nutrition2025-07-31

10.1016/j.ajcnut.2025.07.025

Adipocytokine plasma level changes in a 24-month dietary and physical activity randomised intervention trial in postmenopausal women.

Bendinelli B, Masala G, Bella CD, Assedi M, Benagiano M, Pratesi S, Ermini I, Occhini D, Castaldo M, Saieva C, Caini S, D'Elios MM, Palli D.

2022-12-014 citations

10.1007/s00394-022-03055-y

The DAMA trial: a diet and physical activity intervention trial to reduce mammographic breast density in postmenopausal women in Tuscany, Italy. Study protocol and baseline characteristics.

Giovanna Masala, Melania Assedi, Saverio Caini, Ilaria Ermini, Daniela Occhini et al. (12 authors)

PubMed2014-12-058 citations

10.1700/1636.17890

Musculoskeletal pain in women from DAMA Trial: role of a physical activity intervention

Mirca Marini, Benedetta Bendinelli, Marco Monaci, Melania Assedi, Daniela Occhini et al. (12 authors)

2014-09-01

10.13128/ijae-14887

Interventions

After a baseline visit in which blood and urine samples, anthropometric measurements, dietary and lifestyle information are collected, subjects are randomized to one of the treatment arms (dietary int

nutritional value of foods

energy balance

readiness to change. Participants are also invited to eight practical cooking sessions, led by a professional cook and by a study dietitian, in an appropriate facility. Dishes are prepared according t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Postmenopausal women aged 50-69 years, with a high-density mammographic pattern as routinely assessed in the local screening program by a semi-quantitative method (> 50% high-density area)

Exclusion criteria

Exclusion criteria: 1. Pre- or peri-menopausal status 2. Current or recent (last 12 months) hormone replacement therapy 3. Current smokers 4. Diabetes and/or other major co-morbidities that could affect the possibility to follow the intervention protocol (major cardiovascular diseases, severe hip or knee osteoarthritis) 5. Previous diagnosis of breast cancer or other malignancies

Design outcomes

Primary

Measure	Time frame
Absolute change in percent breast density, calculated as the difference between end of study and baseline percent density values, as assessed on the cranio-caudal view of the right breast of the baseline and follow-up mammograms of each participant. Follow-up mammograms will be performed in a specific time-window (24+3 months after randomization) in the intervention and control groups. All mammograms will be performed in the frame of the local screening program with the same digital mammography equipment. MBD will be assessed on each mammogram using a previously validated computer-assisted technique (Boyd et al., JNCI, 1995) by a study radiologist .Measurements will be done in batches including 80-100 matched mammograms randomly selected from the baseline and follow-up mammograms. Radiologists will be blind to the treatment status and to the sequence of the mammograms.	—

Measure

Time frame

Absolute change in percent breast density, calculated as the difference between end of study and baseline percent density values, as assessed on the cranio-caudal view of the right breast of the baseline and follow-up mammograms of each participant. Follow-up mammograms will be performed in a specific time-window (24+3 months after randomization) in the intervention and control groups. All mammograms will be performed in the frame of the local screening program with the same digital mammography equipment. MBD will be assessed on each mammogram using a previously validated computer-assisted technique (Boyd et al., JNCI, 1995) by a study radiologist .Measurements will be done in batches including 80-100 matched mammograms randomly selected from the baseline and follow-up mammograms. Radiologists will be blind to the treatment status and to the sequence of the mammograms.

—

Secondary

Measure	Time frame
1. Absolute change in area of dense tissue and area of non-dense tissue. These measurements are derived through the same procedures described for the primary outcome 2. Biological samples collected at the first and at the last visit, aliquoted (serum, plasma, buffy coat) and stored in the biological bank of the project will be used to monitor dietary compliance (biomarkers of intake) and to study the effect of the intervention on other outcomes related to breast cancer risk [i.e. plasma levels of sexual hormones, growth factors as insulin-like growth factor 1 (IGF-I) and its binding proteins, urine biomarkers] according also to specific genetic polymorphisms. Biomarkers will be measured depending on the availability of additional funding and, when appropriate, after a specific evaluation by the local Ethics Committee that have already approved the overall project.	—

Measure

Time frame

1. Absolute change in area of dense tissue and area of non-dense tissue. These measurements are derived through the same procedures described for the primary outcome 2. Biological samples collected at the first and at the last visit, aliquoted (serum, plasma, buffy coat) and stored in the biological bank of the project will be used to monitor dietary compliance (biomarkers of intake) and to study the effect of the intervention on other outcomes related to breast cancer risk [i.e. plasma levels of sexual hormones, growth factors as insulin-like growth factor 1 (IGF-I) and its binding proteins, urine biomarkers] according also to specific genetic polymorphisms. Biomarkers will be measured depending on the availability of additional funding and, when appropriate, after a specific evaluation by the local Ethics Committee that have already approved the overall project.

—

Countries

Italy

Outcome results

None listed