Overview

Diet, Exercise and Vitamin D in Breast Cancer Recurrence

Status:
Active, not recruiting
Trial end date:
2023-12-15
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute, Naples
Collaborators:
Unity Health Toronto
University of Catania
Treatments:
Ergocalciferols
Vitamin D
Vitamins
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