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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005147-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| University of Catania | OTHER |
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The purpose of this study is to reduce breast cancer recurrence and hence increase disease-free survival through a lifestyle program that includes a low glycemic diet, physical activity and vitamin D supplementation in women with breast cancer living in a Mediterranean country.
The aim of this study is to reduce breast cancer recurrence and hence increase disease-free survival through either a high intensity or a lower intensity lifestyle program that includes low glycemic index diet, physical activity and supplementation with vitamin D, for 33 months, in women living in Italy who have been surgically treated for breast cancer (either late stage or early stage but highly proliferative) within the previous 12 months. The objectives of the study are: to determine if the high intensity program is more efficacious than the lower intensity program in: 1) reducing breast cancer recurrence and 2) improving glycemic, hormonal, cardiovascular and cancer-related epigenetic markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (high intensity program): | Experimental | Diet: low glycemic index (GI) Mediterranean diet. All carbohydrate foods will be low GI choices (GI<70 on bread scale, e.g. legumes, pasta al dente, barley, oat, apples, oranges, berries, nuts) within a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA). Moderate physical activity: brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity. Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach blood levels of 60-80 ng/ml of 25(OH)D. |
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| Group B (lower intensity program) | Active Comparator | Diet: general recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA). Basic physical activity: general recommendations to avoid sedentary behaviour. Vitamin D supplement (cholecalciferol) will be given only if vitamin D insufficiency is detected to reach blood levels of 30 ng/ml of 25(OH)D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low Glycemic Index Mediterranean diet | Other | All carbohydrate foods will be low GI choices (GI<70 on bread scale, e.g. legumes, pasta al dente, barley, oat, apples, oranges, berries, nuts) within a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA). |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of disease at study end | Disease-free survival (DFS) calculated as the percentage of patients alive without | 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in glycemic markers | blood levels of glucose, glycated hemoglobin, insulin | up to 33 months |
| Changes in hormonal markers | insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Egidio Celentano, M.D. | National Cancer Institute IRCCS Pascale Naples (Italy) | Principal Investigator |
| Livia S Augustin, PhD | National Cancer Institute IRCCS Pascale Naples (Italy) | Principal Investigator |
| Massimo Libra, M.D. | University of Catania, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Riferimento Oncologico | Aviano | Italy | ||||
| Azienda Ospedaliera Cannizzaro |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28114909 | Derived | Augustin LS, Libra M, Crispo A, Grimaldi M, De Laurentiis M, Rinaldo M, D'Aiuto M, Catalano F, Banna G, Ferrau' F, Rossello R, Serraino D, Bidoli E, Massarut S, Thomas G, Gatti D, Cavalcanti E, Pinto M, Riccardi G, Vidgen E, Kendall CW, Jenkins DJ, Ciliberto G, Montella M. Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial. BMC Cancer. 2017 Jan 23;17(1):69. doi: 10.1186/s12885-017-3064-4. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Mediterranean diet | Other | General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA). |
|
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| Moderate physical activity | Behavioral | Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity. |
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| Basic physical activity | Behavioral | General recommendations for physical activity |
|
| high level Vitamin D | Drug | Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D. |
|
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| normal level Vitamin D | Drug | Vitamin D (cholecalciferol) will be given only if vitamin D insufficiency is detected to bring blood levels up to normal ranges of 30ng/mL. |
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| upt to 33 months |
| Changes in cardiovascular risk factors | body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein | up to 33 months |
| Changes in epigenetic factors | microRNA | up to 33 months |
| Catania |
| Italy |
| Clinica Mediterranea | Naples | Italy |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Italy |
| Ospedale dei Colli Monaldi | Naples | Italy |
| Ospedale Evangelico Betania | Naples | Italy |
| Ospedale San Vincenzo | Taormina | Italy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |