NCT02786875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
506

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Nov 2016

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

November 4, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3.9 years

First QC Date

May 6, 2016

Last Update Submit

May 20, 2022

Conditions

Breast Cancer

Keywords

lifestylelow glycemic index dietexercisevitamin Dbreast cancerMediterranean diet

Outcome Measures

Primary Outcomes (1)

  • Recurrence of disease at study end

    Disease-free survival (DFS) calculated as the percentage of patients alive without

    33 months

Secondary Outcomes (4)

  • Changes in glycemic markers

    up to 33 months

  • Changes in hormonal markers

    upt to 33 months

  • Changes in cardiovascular risk factors

    up to 33 months

  • Changes in epigenetic factors

    up to 33 months

Study Arms (2)

Group A (high intensity program):

EXPERIMENTAL

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 dietBehavioral: Moderate physical activityDrug: high level Vitamin D

Group B (lower intensity program)

ACTIVE COMPARATOR

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 dietBehavioral: Basic physical activityDrug: normal level Vitamin D

Interventions

low Glycemic Index Mediterranean dietOTHER

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).

Also known as: Arm A
Group A (high intensity program):
Mediterranean dietOTHER

General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, \<7% SFA).

Also known as: Arm B
Group B (lower intensity program)
Moderate physical activityBEHAVIORAL

Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.

Group A (high intensity program):
Basic physical activityBEHAVIORAL

General recommendations for physical activity

Group B (lower intensity program)
high level Vitamin DDRUG

Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.

Also known as: Dibase
Group A (high intensity program):
normal level Vitamin DDRUG

Vitamin D (cholecalciferol) will be given only if vitamin D insufficiency is detected to bring blood levels up to normal ranges of 30ng/mL.

Also known as: Dibase
Group B (lower intensity program)

Eligibility Criteria

Age30 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centro Riferimento Oncologico

Aviano, Italy

Location

Azienda Ospedaliera Cannizzaro

Catania, Italy

Location

Clinica Mediterranea

Napoli, Italy

Location

Istituto Nazionale Tumori Fondazione G. Pascale

Napoli, Italy

Location

Ospedale dei Colli Monaldi

Napoli, Italy

Location

Ospedale Evangelico Betania

Napoli, Italy

Location

Ospedale San Vincenzo

Taormina, Italy

Location

Related Publications (1)

  • 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.

    PMID: 28114909DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Diet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

June 1, 2016

Study Start

November 4, 2016

Primary Completion

October 10, 2020

Study Completion

December 15, 2023

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(7)