NCT02786875: DEDiCa

Diet, Exercise and Vitamin D in Breast Cancer Recurrence

Status unknown Phase 3 Last updated 23 May 2022

What this trial tests

Phase 3 trial testing low Glycemic Index Mediterranean diet in Breast Cancer in 506 participants. Status unknown.

Timeline

4 November 2016

Primary endpoint
10 October 2020

15 December 2023

Quick facts

Lead sponsor	National Cancer Institute, Naples
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	506
Start date	4 November 2016
Primary completion	10 October 2020
Estimated completion	15 December 2023
Sites	7 locations across Italy

Drugs / interventions tested

• low Glycemic Index Mediterranean diet
• Mediterranean diet
• Moderate physical activity
• Basic physical activity
• high level Vitamin D — full drug profile →
• normal level Vitamin D — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

National Cancer Institute, Naples

Who can join

Adults 30 to 74, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Wnt signaling in breast cancer: biological mechanisms, challenges and opportunities.
   Xu X, Zhang M, Xu F, Jiang S. · · 2020 · cited 450× · PMID 33234169 · DOI 10.1186/s12943-020-01276-5
2. Cancer-Associated Fibroblasts and Tumor-Associated Macrophages in Cancer and Cancer Immunotherapy.
   Raskov H, Orhan A, Gaggar S, Gögenur I. · · 2021 · cited 99× · PMID 34094963 · DOI 10.3389/fonc.2021.668731
3. microRNA-based diagnostic and therapeutic applications in cancer medicine.
   Sempere LF, Azmi AS, Moore A. · · 2021 · cited 97× · PMID 33998154 · DOI 10.1002/wrna.1662
4. Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications.
   Montagnese C, Porciello G, Vitale S, Palumbo E, et al · · 2020 · cited 68× · PMID 33396551 · DOI 10.3390/nu13010136
5. Epidemiology and biology of physical activity and cancer recurrence.
   Friedenreich CM, Shaw E, Neilson HK, Brenner DR. · · 2017 · cited 65× · PMID 28620703 · DOI 10.1007/s00109-017-1558-9
6. Identification of Modulated MicroRNAs Associated with Breast Cancer, Diet, and Physical Activity.
   Falzone L, Grimaldi M, Celentano E, Augustin LSA, et al · · 2020 · cited 55× · PMID 32911851 · DOI 10.3390/cancers12092555
7. Mediterranean diet and quality of life in women treated for breast cancer: A baseline analysis of DEDiCa multicentre trial.
   Porciello G, Montagnese C, Crispo A, Grimaldi M, et al · · 2020 · cited 49× · PMID 33031478 · DOI 10.1371/journal.pone.0239803
8. Antioxidants for the Treatment of Breast Cancer: Are We There Yet?
   Griñan-Lison C, Blaya-Cánovas JL, López-Tejada A, Ávalos-Moreno M, et al · · 2021 · cited 43× · PMID 33572626 · DOI 10.3390/antiox10020205