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

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ClinicalTrials.gov Identifier: NCT02786875
Recruitment Status : Recruiting
First Posted : June 1, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
University of Catania
Information provided by (Responsible Party):
National Cancer Institute, Naples

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.

Condition or disease Intervention/treatment Phase
Breast Cancer 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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 506 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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).

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.

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).

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.




Primary Outcome Measures :
  1. Disease-free survival (DFS) calculated as the percentage of patients alive without recurrence of disease at study end (up to 33 months from randomization). [ Time Frame: 33 months ]

Secondary Outcome Measures :
  1. Changes in glycemic markers [ Time Frame: up to 33 months ]
    blood levels of glucose, glycated hemoglobin, insulin

  2. Changes in hormonal markers [ Time Frame: upt to 33 months ]
    insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)

  3. Changes in cardiovascular risk factors [ Time Frame: up to 33 months ]
    body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein

  4. Changes in epigenetic factors [ Time Frame: up to 33 months ]
    microRNA



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786875


Contacts
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Contact: Livia S Augustin, PhD +39 081 5903395 livia.augustin@utoronto.ca
Contact: Maria Grimaldi, DSc +39 081 5903395 m.grimaldi@istitutotumori.na.it

Locations
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Italy
Centro Riferimento Oncologico Recruiting
Aviano, Italy
Contact: Diego Serraino, MD         
Azienda Ospedaliera Cannizzaro Recruiting
Catania, Italy
Contact: Francesca Catalano, MD         
Clinica Mediterranea Recruiting
Napoli, Italy
Contact: Guglielmo Thomas, MD         
Istituto Nazionale Tumori Fondazione G. Pascale Recruiting
Napoli, Italy
Contact: Livia S Augustin, PhD         
Ospedale dei Colli Monaldi Not yet recruiting
Napoli, Italy
Contact: Vincenzo Montesarchio, MD         
Ospedale Evangelico Betania Recruiting
Napoli, Italy
Contact: Gennaro Guerra, MD         
Istituto NazionaleTumori Regina Elena Not yet recruiting
Roma, Italy
Contact: Patrizia Vici, MD         
Ospedale San Vincenzo Recruiting
Taormina, Italy
Contact: Francesco Ferrau', MD         
Sponsors and Collaborators
National Cancer Institute, Naples
St. Michael's Hospital, Toronto
University of Catania
Investigators
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Principal Investigator: Gerardo Botti, M.D. National Cancer Institute Naples (Italy)
Principal Investigator: Livia S Augustin, PhD St. Michael's Hospital, Toronto, Canada; NCI Naples, Italy
Principal Investigator: Massimo Libra, M.D. University of Catania, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT02786875    
Other Study ID Numbers: DEDiCa
2015-005147-14 ( EudraCT Number )
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by National Cancer Institute, Naples:
lifestyle
low glycemic index diet
exercise
vitamin D
breast cancer
Mediterranean diet
Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents