Diet, Exercise and Vitamin D in Breast Cancer Recurrence

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.

Conditions

• Breast Cancer

Interventions

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.

Sponsors & Collaborators

• Unity Health Toronto

  collaborator OTHER

• University of Catania

  collaborator OTHER

• National Cancer Institute, Naples

  lead OTHER

Principal Investigators

• Egidio Celentano, M.D. · National Cancer Institute IRCCS Pascale Naples (Italy)

• Livia S Augustin, PhD · National Cancer Institute IRCCS Pascale Naples (Italy)

• Massimo Libra, M.D. · University of Catania, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

74 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-04

Primary Completion

2020-10-10

Completion

2023-12-15

Countries

• Italy

Study Locations