The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 506
- 试验地点
- 7
- 主要终点
- Recurrence of disease at study end
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with primary diagnosis of histologically confirmed breast cancer (T1 with Ki67≥30%, T2, T3 without metastasis) within 12 months from diagnosis.
- •Age ≥ 30 and < 75 years.
- •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.
排除标准
- •Patients who do not possess the inclusion criteria for this study.
- •Patients with sarcoidosis or other granulomatous diseases or with hypercalcemia (Ca>11mg/dL).
- •Patients with any previous or current concomitant other malignant cancer.
- •Pregnant or lactating women.
- •Patients with AIDS diagnosis
- •Patients with severe renal insufficiency
- •Patients with kidney stones (nephrocalcinosis or nephrolithiasis)
- •Patients participating in other lifestyle clinical trials
研究组 & 干预措施
Group A (high intensity program):
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.
干预措施: low Glycemic Index Mediterranean diet (Other)
Group A (high intensity program):
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.
干预措施: Moderate physical activity (Behavioral)
Group A (high intensity program):
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.
干预措施: high level Vitamin D (Drug)
Group B (lower intensity program)
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.
干预措施: Mediterranean diet (Other)
Group B (lower intensity program)
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.
干预措施: Basic physical activity (Behavioral)
Group B (lower intensity program)
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.
干预措施: normal level Vitamin D (Drug)
结局指标
主要结局
Recurrence of disease at study end
时间窗: 33 months
Disease-free survival (DFS) calculated as the percentage of patients alive without
次要结局
- Changes in hormonal markers(upt to 33 months)
- Changes in cardiovascular risk factors(up to 33 months)
- Changes in glycemic markers(up to 33 months)
- Changes in epigenetic factors(up to 33 months)