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Breast CancerPhase 3DEDiCaNCT02786875

Diet, Exercise and Vitamin D in Breast Cancer Recurrence

A Phase 3 study testing low Glycemic Index Mediterranean diet, Mediterranean diet and Moderate physical activity in people with Breast Cancer, run by National Cancer Institute, Naples at 7 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 74 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
low Glycemic Index Mediterranean diet, Mediterranean diet and Moderate physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
506 participants
Where
7 sitesItaly
Study dates
4 Nov 2016to 15 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Italy7 sites

  • Centro Riferimento Oncologico

    Aviano

  • Azienda Ospedaliera Cannizzaro

    Catania

  • Clinica Mediterranea

    Naples

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples

  • Ospedale dei Colli Monaldi

    Naples

  • Ospedale Evangelico Betania

    Naples

  • Ospedale San Vincenzo

    Taormina

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
low Glycemic Index Mediterranean diet, Mediterranean diet, Moderate physical activity, Basic physical activity, high level Vitamin D
Keywords
lifestyle, low glycemic index diet, exercise, vitamin D, breast cancer, Mediterranean diet
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low Glycemic Index Mediterranean dietOther

    Also called Arm A

    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).

  • Mediterranean dietOther

    Also called Arm B

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

  • Moderate physical activityBehavioural

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

  • Basic physical activityBehavioural

    General recommendations for physical activity

  • high level Vitamin DDrug

    Also called Dibase

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

  • normal level Vitamin DDrug

    Also called Dibase

    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 groups in NCT02786875
Study groupRoleWhat they receive
Group A (high intensity program):ExperimentalDiet: 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.
Receives: Other: low Glycemic Index Mediterranean diet; Behavioral: Moderate physical activity; Drug: high level Vitamin D
Group B (lower intensity program)Active comparatorDiet: 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.
Receives: Other: Mediterranean diet; Behavioral: Basic physical activity; Drug: normal level Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of disease at study end

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

    Measured: 33 months

Secondary outcomes (4)

  1. Changes in glycemic markers

    blood levels of glucose, glycated hemoglobin, insulin

    Measured: up to 33 months

  2. Changes in hormonal markers

    insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)

    Measured: upt to 33 months

  3. Changes in cardiovascular risk factors

    body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein

    Measured: up to 33 months

  4. Changes in epigenetic factors

    microRNA

    Measured: up to 33 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2016 (estimated)
  2. Study start4 Nov 2016
  3. Primary completion10 Oct 2020
  4. Study completion15 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02786875
Sponsor's protocol ID
DEDiCa
Other IDs
2015-005147-14, 2015
Acronym
DEDiCa
Status last verified
May 2022
First submitted
6 May 2016
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 28114909

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing low Glycemic Index Mediterranean diet, Mediterranean diet and Moderate physical activity in people with Breast Cancer, run by National Cancer Institute, Naples at 7 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of disease at study end (time frame: 33 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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