Diet, Exercise and Vitamin D in Breast Cancer Recurrence (DEDiCa)
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| ClinicalTrials.gov Identifier: NCT02786875 |
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Recruitment Status :
Recruiting
First Posted : June 1, 2016
Last Update Posted : February 5, 2020
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Sponsor:
National Cancer Institute, Naples
Collaborators:
Unity Health Toronto
University of Catania
Information provided by (Responsible Party):
National Cancer Institute, Naples
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Other: low Glycemic Index Mediterranean diet Other: Mediterranean diet Behavioral: Moderate physical activity Behavioral: Basic physical activity Drug: high level Vitamin D Drug: normal level Vitamin D | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 506 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study |
| Actual Study Start Date : | November 2016 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
Drug Information available for:
Vitamin D
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
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). Behavioral: Moderate physical activity Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual 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. |
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Active Comparator: 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. |
Other: 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: Basic physical activity General recommendations for physical activity Drug: 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. |
Primary Outcome Measures :
- Disease-free survival (DFS) calculated as the percentage of patients alive without recurrence of disease at study end (up to 33 months from randomization). [ Time Frame: 33 months ]
Secondary Outcome Measures :
- Changes in glycemic markers [ Time Frame: up to 33 months ]blood levels of glucose, glycated hemoglobin, insulin
- Changes in hormonal markers [ Time Frame: upt to 33 months ]insulin-like growth factor-1 (IGF-1), estradiol, testosterone, sex hormone binding globulin (SHBG)
- Changes in cardiovascular risk factors [ Time Frame: up to 33 months ]body weight, waist circumference, blood pressure, cholesterol, triglycerides, C-reactive protein
- Changes in epigenetic factors [ Time Frame: up to 33 months ]microRNA
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| Ages Eligible for Study: | 30 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786875
Contacts
| Contact: Livia S Augustin, PhD | +39 081 5903395 | livia.augustin@utoronto.ca | |
| Contact: Maria Grimaldi, DSc | +39 081 5903395 | m.grimaldi@istitutotumori.na.it |
Locations
| Italy | |
| Centro Riferimento Oncologico | Recruiting |
| Aviano, Italy | |
| Contact: Diego Serraino, MD | |
| Azienda Ospedaliera Cannizzaro | Recruiting |
| Catania, Italy | |
| Contact: Francesca Catalano, MD | |
| Clinica Mediterranea | Recruiting |
| Napoli, Italy | |
| Contact: Guglielmo Thomas, MD | |
| Istituto Nazionale Tumori Fondazione G. Pascale | Recruiting |
| Napoli, Italy | |
| Contact: Livia S Augustin, PhD | |
| Ospedale dei Colli Monaldi | Not yet recruiting |
| Napoli, Italy | |
| Contact: Vincenzo Montesarchio, MD | |
| Ospedale Evangelico Betania | Recruiting |
| Napoli, Italy | |
| Contact: Gennaro Guerra, MD | |
| Istituto NazionaleTumori Regina Elena | Not yet recruiting |
| Roma, Italy | |
| Contact: Patrizia Vici, MD | |
| Ospedale San Vincenzo | Recruiting |
| Taormina, Italy | |
| Contact: Francesco Ferrau', MD | |
Sponsors and Collaborators
National Cancer Institute, Naples
Unity Health Toronto
University of Catania
Investigators
| Principal Investigator: | Gerardo Botti, M.D. | National Cancer Institute Naples (Italy) | |
| Principal Investigator: | Livia S Augustin, PhD | St. Michael's Hospital, Toronto, Canada; NCI Naples, Italy | |
| Principal Investigator: | Massimo Libra, M.D. | University of Catania, Italy |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Cancer Institute, Naples |
| ClinicalTrials.gov Identifier: | NCT02786875 |
| Other Study ID Numbers: |
DEDiCa 2015-005147-14 ( EudraCT Number ) |
| First Posted: | June 1, 2016 Key Record Dates |
| Last Update Posted: | February 5, 2020 |
| Last Verified: | November 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by National Cancer Institute, Naples:
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lifestyle low glycemic index diet exercise |
vitamin D breast cancer Mediterranean diet |
Additional relevant MeSH terms:
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Breast Neoplasms Recurrence Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Disease Attributes Pathologic Processes Vitamin D |
Ergocalciferols Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |