Diet, Exercise and Vitamin D in Breast Cancer Recurrence (DEDiCa)

May 20, 2022 updated by: National Cancer Institute, Naples

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

506

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Aviano, Italy
        • Centro Riferimento Oncologico
      • Catania, Italy
        • Azienda Ospedaliera Cannizzaro
      • Napoli, Italy
        • Clinica Mediterranea
      • Napoli, Italy
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Napoli, Italy
        • Ospedale dei Colli Monaldi
      • Napoli, Italy
        • Ospedale Evangelico Betania
      • Taormina, Italy
        • Ospedale San Vincenzo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (high intensity program):

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
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 Names:
  • Arm A
Behavioral: Moderate physical activity
Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual 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.
Other Names:
  • Dibase
Active Comparator: Group B (lower intensity program)

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
General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA).
Other Names:
  • Arm B
Behavioral: Basic physical activity
General recommendations for physical activity
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.
Other Names:
  • Dibase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of disease at study end
Time Frame: 33 months
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
Time Frame: up to 33 months
blood levels of glucose, glycated hemoglobin, insulin
up to 33 months
Changes in hormonal markers
Time Frame: upt to 33 months
insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)
upt to 33 months
Changes in cardiovascular risk factors
Time Frame: up to 33 months
body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein
up to 33 months
Changes in epigenetic factors
Time Frame: up to 33 months
microRNA
up to 33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Collaborators

Unity Health Toronto
University of Catania

Investigators

  • Principal Investigator: Egidio Celentano, M.D., National Cancer Institute IRCCS Pascale Naples (Italy)
  • Principal Investigator: Livia S Augustin, PhD, National Cancer Institute IRCCS Pascale Naples (Italy)
  • Principal Investigator: Massimo Libra, M.D., University of Catania, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2016

Primary Completion (Actual)

October 10, 2020

Study Completion (Anticipated)

December 15, 2023

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 25, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEDiCa
  • 2015-005147-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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