Diet, Exercise and Vitamin D in Breast Cancer Recurrence
NCT ID: NCT02786875
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
506 participants
INTERVENTIONAL
2016-11-04
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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).
Moderate physical activity
Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.
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.
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.
Mediterranean 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 for physical activity
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.
Interventions
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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).
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
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
30 Years
74 Years
FEMALE
No
Sponsors
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Unity Health Toronto
OTHER
University of Catania
OTHER
National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Egidio Celentano, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute IRCCS Pascale Naples (Italy)
Livia S Augustin, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute IRCCS Pascale Naples (Italy)
Massimo Libra, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Catania, Italy
Locations
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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, , Italy
Countries
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References
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Augustin LS, Libra M, Crispo A, Grimaldi M, De Laurentiis M, Rinaldo M, D'Aiuto M, Catalano F, Banna G, Ferrau' F, Rossello R, Serraino D, Bidoli E, Massarut S, Thomas G, Gatti D, Cavalcanti E, Pinto M, Riccardi G, Vidgen E, Kendall CW, Jenkins DJ, Ciliberto G, Montella M. Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial. BMC Cancer. 2017 Jan 23;17(1):69. doi: 10.1186/s12885-017-3064-4.
Other Identifiers
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2015-005147-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DEDiCa
Identifier Type: -
Identifier Source: org_study_id
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