Diet, Exercise and Vitamin D in Breast Cancer Recurrence

Phase 3

• Conditions: Breast Cancer
• Interventions: Other: Mediterranean diet; Other: low Glycemic Index Mediterranean diet; Behavioral: Moderate physical activity; Behavioral: Basic physical activity; Drug: high level Vitamin D; Drug: normal level Vitamin D

• Registration Number: NCT02786875
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-06-01
• Study Start: 2016-11-04
• Primary Completion: 2020-10-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-23
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 506

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (high intensity program):	Moderate physical activity	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.
Group A (high intensity program):	high level Vitamin D	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.
Group B (lower intensity program)	Mediterranean diet	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.
Group B (lower intensity program)	Basic physical activity	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.
Group A (high intensity program):	low Glycemic Index Mediterranean diet	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.
Group B (lower intensity program)	normal level Vitamin D	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.

Primary Outcome Measures

Name	Time	Method
Recurrence of disease at study end	33 months	Disease-free survival (DFS) calculated as the percentage of patients alive without

Secondary Outcome Measures

Name	Time	Method
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 glycemic markers	up to 33 months	blood levels of glucose, glycated hemoglobin, insulin
Changes in epigenetic factors	up to 33 months	microRNA

Trial Locations

Locations (7)

Istituto Nazionale Tumori Fondazione G. Pascale; 🇮🇹 Napoli, Italy

Ospedale Evangelico Betania; 🇮🇹 Napoli, Italy

Clinica Mediterranea; 🇮🇹 Napoli, Italy

Centro Riferimento Oncologico; 🇮🇹 Aviano, Italy

Azienda Ospedaliera Cannizzaro; 🇮🇹 Catania, Italy

Ospedale dei Colli Monaldi; 🇮🇹 Napoli, Italy

Ospedale San Vincenzo; 🇮🇹 Taormina, Italy