Diet, Exercise and Vitamin D in Breast Cancer Recurrence (DEDiCa)

National Cancer Institute, Naples

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Other: Mediterranean diet; Behavioral: Moderate physical activity; Behavioral: Basic physical activity; Other: low Glycemic Index Mediterranean diet; Drug: normal level Vitamin D; Drug: high level Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT02786875

2015-005147-14 (EudraCT Number)

DEDiCa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 506 patients

Sex: Female

Ages: 30 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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506 participants in 2 patient groups

Group A (high intensity program):

Experimental group

Description:

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.

Treatment:

Drug: high level Vitamin D

Behavioral: Moderate physical activity

Other: low Glycemic Index Mediterranean diet

Group B (lower intensity program)

Active Comparator group

Description:

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.

Treatment:

Drug: normal level Vitamin D

Behavioral: Basic physical activity

Other: Mediterranean diet