NCT02786875

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: Female
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	low Glycemic Index 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).
OTHER	Mediterranean diet	General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, \<7% SFA).
BEHAVIORAL	Moderate physical activity	Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.
BEHAVIORAL	Basic physical activity	General recommendations for physical activity
DRUG	high level Vitamin D	Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.
DRUG	normal 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.

Timeline

• Start date: 2016-11-04
• Primary completion: 2020-10-10
• Completion: 2023-12-15
• First posted: 2016-06-01
• Last updated: 2022-05-23

Locations

7 sites across 1 country: Italy