Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Recurrence

Breast Neoplasms

Breast Diseases

Skin Diseases

Disease Attributes

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Herbal and Botanical

Vitamins

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Orange

Vitamin D3

Calciferol

Barley

Ergocalciferol

Vitamin D2

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.

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.

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).

low Glycemic Index Mediterranean diet

General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, \<7% SFA).

Mediterranean diet

Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.

Moderate physical activity

General recommendations for physical activity

Basic physical activity

Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.

high level Vitamin D

Vitamin D (cholecalciferol) will be given only if vitamin D insufficiency is detected to bring blood levels up to normal ranges of 30ng/mL.

normal level Vitamin D

Egidio Celentano, M.D.

Livia S Augustin, PhD

Massimo Libra, M.D.

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.

Diet, Exercise and Vitamin D in Breast Cancer Recurrence

The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study

Disease-free survival (DFS) calculated as the percentage of patients alive without

blood levels of glucose, glycated hemoglobin, insulin

insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)

body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diet, Exercise and Vitamin D in Breast Cancer Recurrence	NCT02786875	Breast Cancer	low Glycemic In... Mediterranean d... Moderate physic... Basic physical ... high level Vita... normal level Vi...	30 Years - 74 Years	National Cancer Institute, Naples
Diet, Exercise and Vitamin D in Breast Cancer Recurrence	NCT02786875	Breast Cancer	low Glycemic In... Mediterranean d... Moderate physic... Basic physical ... high level Vita... normal level Vi...	30 Years - 74 Years	National Cancer Institute, Naples

Spots Global Cancer Trial Database for moderate physical activity