Diet, Exercise and Vitamin D in Breast Cancer Recurrence

Breast Cancer Clinical Trial

— DEDiCa  

Official title:

The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02786875
• Other study ID #: DEDiCa
• Secondary ID: 2015-005147-14
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 4, 2016
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2022
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 506
• Est. completion date: December 15, 2023
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrence

Intervention

Other:
• low Glycemic Index 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).
• Mediterranean diet
General recommendations for a healthy Mediterranean diet (=5 servings veg/fruit per day, =1 serving red meat+cold cuts/week, <7% SFA).

Behavioral:
• Moderate physical activity
Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.
• Basic physical activity
General recommendations for physical activity

Drug:
• high 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.
• normal 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.

Locations

Country	Name	City	State
Italy	Centro Riferimento Oncologico	Aviano
Italy	Azienda Ospedaliera Cannizzaro	Catania
Italy	Clinica Mediterranea	Napoli
Italy	Istituto Nazionale Tumori Fondazione G. Pascale	Napoli
Italy	Ospedale dei Colli Monaldi	Napoli
Italy	Ospedale Evangelico Betania	Napoli
Italy	Ospedale San Vincenzo	Taormina

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Institute, Naples	Unity Health Toronto, University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of disease at study end	Disease-free survival (DFS) calculated as the percentage of patients alive without	33 months
Secondary	Changes in glycemic markers	blood levels of glucose, glycated hemoglobin, insulin	up to 33 months
Secondary	Changes in hormonal markers	insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)	upt to 33 months
Secondary	Changes in cardiovascular risk factors	body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein	up to 33 months
Secondary	Changes in epigenetic factors	microRNA	up to 33 months