Spots Global Cancer Trial Database for Diet, Exercise and Vitamin D in Breast Cancer Recurrence

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Trial Identification

Brief Title: Diet, Exercise and Vitamin D in Breast Cancer Recurrence

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

Study ID: NCT02786875

Conditions

Breast Cancer

Interventions

low Glycemic Index Mediterranean diet

Mediterranean diet

Moderate physical activity

Basic physical activity

high level Vitamin D

normal level Vitamin D

Study Description

Brief Summary: 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.

Detailed Description: 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.