Clinical trial NCT02786875: Diet, Exercise and Vitamin D in Breast Cancer Recurrence
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: lifestyle
low glycemic index diet
exercise
vitamin D
breast cancer
Mediterranean diet
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
name: University of Catania
First posted: 2016-06-01
Enrollment: 506
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of disease at study end
timeFrame: 33 months
Secondary outcomes:
measure: Changes in glycemic markers
timeFrame: up to 33 months
measure: Changes in hormonal markers
timeFrame: upt to 33 months
measure: Changes in cardiovascular risk factors
timeFrame: up to 33 months
measure: Changes in epigenetic factors
timeFrame: up to 33 months
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro Riferimento Oncologico
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Fondazione G. Pascale
city: Napoli
country: Italy
facility: Ospedale dei Colli Monaldi
city: Napoli
country: Italy
facility: Ospedale Evangelico Betania
city: Taormina
country: Italy
facility: Ospedale San Vincenzo
Study officials:
affiliation: National Cancer Institute IRCCS Pascale Naples (Italy)
name: Egidio Celentano, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute IRCCS Pascale Naples (Italy)
name: Livia S Augustin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Catania, Italy
name: Massimo Libra, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.