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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

Tracking Information
First Submitted Date  ICMJE May 6, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)		 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
  • Changes in glycemic markers [ Time Frame: up to 33 months ]
    blood levels of glucose, glycated hemoglobin, insulin
  • Changes in hormonal markers [ Time Frame: upt to 33 months ]
    insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)
  • Changes in cardiovascular risk factors [ Time Frame: up to 33 months ]
    body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein
  • Changes in epigenetic factors [ Time Frame: up to 33 months ]
    microRNA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diet, Exercise and Vitamin D in Breast Cancer Recurrence
Official Title  ICMJE The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.

    Interventions:
    • Other: low Glycemic Index Mediterranean diet
    • Behavioral: Moderate physical activity
    • Drug: high level Vitamin 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.

    Interventions:
    • Other: Mediterranean diet
    • Behavioral: Basic physical activity
    • Drug: normal level Vitamin D
Publications * Augustin LS, Libra M, Crispo A, Grimaldi M, De Laurentiis M, Rinaldo M, D'Aiuto M, Catalano F, Banna G, Ferrau' F, Rossello R, Serraino D, Bidoli E, Massarut S, Thomas G, Gatti D, Cavalcanti E, Pinto M, Riccardi G, Vidgen E, Kendall CW, Jenkins DJ, Ciliberto G, Montella M. Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial. BMC Cancer. 2017 Jan 23;17(1):69. doi: 10.1186/s12885-017-3064-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)		 506
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Livia S Augustin, PhD +39 081 5903395 livia.augustin@utoronto.ca
Contact: Maria Grimaldi, DSc +39 081 5903395 m.grimaldi@istitutotumori.na.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02786875
Other Study ID Numbers  ICMJE DEDiCa
2015-005147-14 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party National Cancer Institute, Naples
Study Sponsor  ICMJE National Cancer Institute, Naples
Collaborators  ICMJE
  • St. Michael's Hospital, Toronto
  • University of Catania
Investigators  ICMJE
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
PRS Account National Cancer Institute, Naples
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP