Breast Cancer
Conditions
Keywords
lifestyle, low glycemic index diet, exercise, vitamin D, breast cancer, Mediterranean diet
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.
Interventions
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).
OTHERMediterranean diet
General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, \<7% SFA).
BEHAVIORALModerate physical activity
Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.
BEHAVIORALBasic physical activity
General recommendations for physical activity
DRUGhigh level Vitamin D
Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.
DRUGnormal level Vitamin D
Vitamin D (cholecalciferol) will be given only if vitamin D insufficiency is detected to bring blood levels up to normal ranges of 30ng/mL.
Sponsors
Unity Health Toronto
University of Catania
National Cancer Institute, Naples
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of disease at study end | 33 months | Disease-free survival (DFS) calculated as the percentage of patients alive without |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycemic markers | up to 33 months | blood levels of glucose, glycated hemoglobin, insulin |
| Changes in hormonal markers | upt to 33 months | insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG) |
| Changes in cardiovascular risk factors | up to 33 months | body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein |
| Changes in epigenetic factors | up to 33 months | microRNA |
Countries
Italy
Outcome results
None listed