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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
low Glycemic Index Mediterranean diet
Mediterranean diet
Moderate physical activity
Basic physical activity
high level Vitamin D
normal level Vitamin D
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring lifestyle, low glycemic index diet, exercise, vitamin D, breast cancer, Mediterranean diet

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (high intensity program):

Group B (lower intensity program)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrence of disease at study end
Disease-free survival (DFS) calculated as the percentage of patients alive without

Secondary Outcome Measures

Changes in glycemic markers
blood levels of glucose, glycated hemoglobin, insulin
Changes in hormonal markers
insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)
Changes in cardiovascular risk factors
body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein
Changes in epigenetic factors
microRNA

Full Information

First Posted
May 6, 2016
Last Updated
May 20, 2022
Sponsor
National Cancer Institute, Naples
Collaborators
Unity Health Toronto, University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT02786875
Brief Title
Diet, Exercise and Vitamin D in Breast Cancer Recurrence
Acronym
DEDiCa
Official Title
The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2016 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples
Collaborators
Unity Health Toronto, University of Catania

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
lifestyle, low glycemic index diet, exercise, vitamin D, breast cancer, Mediterranean diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
506 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (high intensity program):
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (lower intensity program)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
low Glycemic Index Mediterranean diet
Other Intervention Name(s)
Arm A
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Mediterranean diet
Other Intervention Name(s)
Arm B
Intervention Description
General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA).
Intervention Type
Behavioral
Intervention Name(s)
Moderate physical activity
Intervention Description
Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.
Intervention Type
Behavioral
Intervention Name(s)
Basic physical activity
Intervention Description
General recommendations for physical activity
Intervention Type
Drug
Intervention Name(s)
high level Vitamin D
Other Intervention Name(s)
Dibase
Intervention Description
Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.
Intervention Type
Drug
Intervention Name(s)
normal level Vitamin D
Other Intervention Name(s)
Dibase
Intervention Description
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 Measure Information:
Title
Recurrence of disease at study end
Description
Disease-free survival (DFS) calculated as the percentage of patients alive without
Time Frame
33 months
Secondary Outcome Measure Information:
Title
Changes in glycemic markers
Description
blood levels of glucose, glycated hemoglobin, insulin
Time Frame
up to 33 months
Title
Changes in hormonal markers
Description
insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)
Time Frame
upt to 33 months
Title
Changes in cardiovascular risk factors
Description
body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein
Time Frame
up to 33 months
Title
Changes in epigenetic factors
Description
microRNA
Time Frame
up to 33 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with primary diagnosis of histologically confirmed breast cancer (T1 with Ki67≥30%, T2, T3 without metastasis) within 12 months from diagnosis. Age ≥ 30 and < 75 years. 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: Patients who do not possess the inclusion criteria for this study. Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca>11mg/dL). Patients with any previous or current concomitant other malignant cancer. Pregnant or lactating women. Patients with AIDS diagnosis Patients with severe renal insufficiency Patients with kidney stones (nephrocalcinosis or nephrolithiasis) Patients participating in other lifestyle clinical trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidio Celentano, M.D.
Organizational Affiliation
National Cancer Institute IRCCS Pascale Naples (Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Livia S Augustin, PhD
Organizational Affiliation
National Cancer Institute IRCCS Pascale Naples (Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Libra, M.D.
Organizational Affiliation
University of Catania, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Riferimento Oncologico
City
Aviano
Country
Italy
Facility Name
Azienda Ospedaliera Cannizzaro
City
Catania
Country
Italy
Facility Name
Clinica Mediterranea
City
Napoli
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione G. Pascale
City
Napoli
Country
Italy
Facility Name
Ospedale dei Colli Monaldi
City
Napoli
Country
Italy
Facility Name
Ospedale Evangelico Betania
City
Napoli
Country
Italy
Facility Name
Ospedale San Vincenzo
City
Taormina
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28114909
Citation
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.
Results Reference
derived

Learn more about this trial

Diet, Exercise and Vitamin D in Breast Cancer Recurrence

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