Diet, Exercise and Vitamin D in Breast Cancer Recurrence

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: low Glycemic Index Mediterranean diet
* Other: Mediterranean diet
* Behavioral: Moderate physical activity
* Behavioral: Basic physical activity
* Drug: high level Vitamin D
* Drug: normal level Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with primary diagnosis of histologically confirmed breast cancer (T1 with Ki67≥30%, T2, T3 without metastasis) within 12 months from diagnosis. Age ≥ 30 and < 75 years. Patients who are able to comprehend and are willing to sign the consent form and are able to adhere to the protocol including scheduled clinic visits and assigned treatment. Exclusion Criteria: Patients who do not possess the inclusion criteria for this study. Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca>11mg/dL). Patients with any previous or current concomitant other malignant cancer. Pregnant or lactating women. Patients with AIDS diagnosis Patients with severe renal insufficiency Patients with kidney stones (nephrocalcinosis or nephrolithiasis) Patients participating in other lifestyle clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (high intensity program):<br>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. | Other: low Glycemic Index Mediterranean diet<br>* 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).<br>* Other names: Arm A;Behavioral: Moderate physical activity<br>* Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.<br>Drug: high level Vitamin D<br>* Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.<br>* Other names: Dibase;|
| Active Comparator: Group B (lower intensity program)<br>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. | Other: Mediterranean diet<br>* General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA).<br>* Other names: Arm B;Behavioral: Basic physical activity<br>* General recommendations for physical activity<br>Drug: normal level Vitamin D<br>* Vitamin D (cholecalciferol) will be given only if vitamin D insufficiency is detected to bring blood levels up to normal ranges of 30ng/mL.<br>* Other names: Dibase;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of disease at study end | Disease-free survival (DFS) calculated as the percentage of patients alive without | 33 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lifestyle, low glycemic index diet, exercise, vitamin D, breast cancer, Mediterranean diet