Diet, Exercise and Vitamin D in Breast Cancer Recurrence

National Cancer Institute, Naples506 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

506

Conditions

Breast Cancer

Interventions

low Glycemic Index Mediterranean dietOTHER

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).

Mediterranean dietOTHER

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

Moderate physical activityBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 74 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women with primary diagnosis of histologically confirmed breast cancer (T1 with Ki67≥30%, T2, T3 without metastasis) within 12 months from diagnosis. 2. Age ≥ 30 and \< 75 years. 3. 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: 1. Patients who do not possess the inclusion criteria for this study. 2. Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca\>11mg/dL). 3. Patients with any previous or current concomitant other malignant cancer. 4. Pregnant or lactating women. 5. Patients with AIDS diagnosis 6. Patients with severe renal insufficiency 7. Patients with kidney stones (nephrocalcinosis or nephrolithiasis) 8. Patients participating in other lifestyle clinical trials

Locations (7)

Centro Riferimento Oncologico

Aviano, Italy

Azienda Ospedaliera Cannizzaro

Catania, Italy

Clinica Mediterranea

Naples, Italy

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Italy

Outcomes

Primary Outcomes

Recurrence of disease at study end

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

Time frame: 33 months

Secondary Outcomes

Changes in glycemic markers

blood levels of glucose, glycated hemoglobin, insulin

Time frame: up to 33 months

Changes in hormonal markers

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

Time frame: upt to 33 months

Changes in cardiovascular risk factors

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

Time frame: up to 33 months

Changes in epigenetic factors

microRNA

Time frame: up to 33 months

Data from ClinicalTrials.gov

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