Clinical trial · Interventional
Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention
NCT02035631CI-TRIAL-00013458PREDICOPunknownPhase 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 main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.
Conditions
Conditions (2)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diet | Behavioral | — | UNRESOLVED |
| Minimal diet intervention | Behavioral | — | UNRESOLVED |
| Minimal physical activity intervention | Behavioral | — | UNRESOLVED |
| Physical activity | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Lifestyle intervention combining weight control, diet and physical activity
- interventionNames
- Behavioral: Diet
- Behavioral: Physical activity
- type
- SHAM_COMPARATOR
- label
- Minimal intervention
- description
- Minimal diet intervention and minimal physical activity intervention
- interventionNames
- Behavioral: Minimal diet intervention
- Behavioral: Minimal physical activity intervention
Primary outcomes (1)
- measure
- Time to local and distant recurrence
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * incident primary breast cancer (ICD-O C50) * stage at diagnosis I, II, IIIA (or T1-3, N0-N2, M0) * age at diagnosis below 76 years * within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease Exclusion Criteria: * morbid obesity (BMI \>40kg/m²) or underweight (BMI \<18kg/m²) * ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months * diabetes (only if unstable - glycosylated haemoglobin \>9%) * current medical or surgical treatment to lose weight * mental illness that would prevent the patient from carrying out the intervention * logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments) * pregnant or planning pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.