Clinical trial · Interventional
Diet, Exercise and Vitamin D in Breast Cancer Recurrence
The Effect of the Combination of Low Glycemic Index Diet, Exercise and Vitamin D on Breast Cancer Recurrence: DEDiCa Study
NCT02786875CI-TRIAL-00058664DEDiCaunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basic physical activity | Behavioral | — | UNRESOLVED |
| high level Vitamin D | Drug | — | UNRESOLVED |
| low Glycemic Index Mediterranean diet | Other | — | UNRESOLVED |
| Mediterranean diet | Other | — | UNRESOLVED |
| Moderate physical activity | Behavioral | — | UNRESOLVED |
| normal level Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (high intensity program):
- description
- 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.
- interventionNames
- Other: low Glycemic Index Mediterranean diet
- Behavioral: Moderate physical activity
- Drug: high level Vitamin D
- type
- ACTIVE_COMPARATOR
- label
- Group B (lower intensity program)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAugustin 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. PMID 28114909