Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention (PREDICOP)
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| ClinicalTrials.gov Identifier: NCT02035631 |
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Recruitment Status : Unknown
Verified January 2014 by Institut Català d'Oncologia.
Recruitment status was: Not yet recruiting
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
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Sponsor:
Institut Català d'Oncologia
Information provided by (Responsible Party):
Institut Català d'Oncologia
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Neoplasms Recurrence | Behavioral: Diet Behavioral: Physical activity Behavioral: Minimal diet intervention Behavioral: Minimal physical activity intervention | Phase 3 |
BACKGROUND/MAIN OBJECTIVE: 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. As secondary objectives we aim to assess whether the proposed intervention is able to improve the overall survival or the disease-free survival, as well as quality of life of breast cancer patients. METHODOLOGY: This multicentric randomized controlled trial aims to include 2108 women (1054 per arm), aged up to 75 years, diagnosed with a non-metastatic breast cancer (stage I, II, IIIA) in the participating centres, whose standard treatment was completed within the last 3 months. Participants will be assigned to either an intervention or a control group, and followed for five years. Patients assigned to the control arm will continue with the usual care, including standard guidelines for weight control applied in the centre. Patients in the intervention group will be involved in a lifestyle program with two components. The dietary part will aim to achieve a calorie reduction while maintaining nutritional quality; the physical activity part will include supervised sessions of moderate intensity. Data will be analyzed on an intention to treat basis using time-toevent analysis. HYPOTHESES: We expect a significant reduction in the 5-year cumulative incidence of recurrences (primary outcome) in the intervention group. Furthermore, as secondary outcomes, we expect a significant increase in overall survival and an improvement of quality of life of patients included in the intervention arm.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Prevention of Breast Cancer Recurrence Through Weight Control, Diet, and Physical Activity Intervention |
| Study Start Date : | January 2014 |
| Estimated Primary Completion Date : | January 2022 |
| Estimated Study Completion Date : | January 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
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Experimental: Intervention
Lifestyle intervention combining weight control, diet and physical activity
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Behavioral: Diet
The dietary component, aimed to reduce calorie intake according to individual requirements, will be structured in 1-hour weekly sessions led by trained nutritionists. Sessions will concentrate on teaching participants about food groups, the food pyramid and Mediterranean diet, how to chose, prepare and cook hypo-caloric meals. Behavioral: Physical activity The physical activity component will include two sessions per week led by trained physical activity monitors including aerobic exercise of high/moderate intensity, and instruction about the at-home exercise activities (3 more sessions). |
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Sham Comparator: Minimal intervention
Minimal diet intervention and minimal physical activity intervention
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Behavioral: Minimal diet intervention
Some basic diet recommendations Behavioral: Minimal physical activity intervention Some basic recommendations on physical activity |
Primary Outcome Measures :
- Time to local and distant recurrence [ Time Frame: 5 years from recruitment day ]Time between recruitment date and local and distant recurrence date or end of the 5-year follow-up which ever occurs first
Secondary Outcome Measures :
- Overall survival [ Time Frame: 5 years ]Time between recruitment date and death date or end of 5-year follow-up which ever occurs first
- Disease free survival [ Time Frame: 5 years ]Time between recruitment date and recurrence (local or distant) or death or end of 5-year follow-up which ever occurs first
- Quality of life [ Time Frame: Baseline, one year and three years ]Quality of life assessments using the SF36, the FACIT (fatigue questionnaire) and the HADS (Anxiety and depression)
Other Outcome Measures:
- Changes in biomarkers [ Time Frame: Baseline and one year ]
Biomarkers related to:
- sex hormone profile,
- dietary intake,
- insulin resistance,
- inflammation process
- and any biomarker possibly related to the progression of the disease.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
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): NCT02035631
Contacts
| Contact: Antonio Agudo, MD-PhD | +34 932607401 | a.agudo@iconcologia.net | |
| Contact: Noemie Travier, MSc | +34 932607401 | ntravier@iconcologia.net |
Locations
| Spain | |
| Fundació Institut d'Investigació Germans Trias i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Contact: Beatriz Cirauqui Cirauqui, MD +34 934978925 bcirauqui@iconcologia.net | |
| Principal Investigator: Beatriz Cirauqui Cirauqui, MD | |
| Institut Catala d'Oncologia - L'Hospitalet | |
| L'Hospitalet de llobregat, Barcelona, Spain, 08908 | |
| Contact: Antonio Agudo, MD +34 932607401 a.agudo@iconcologia.net | |
| Principal Investigator: Antonio Agudo, MD | |
| Consorci Sanitari de Terrassa | |
| Terrassa, Barcelona, Spain, 08227 | |
| Contact: Maria Angeles Arcusa Lanza, MD +34 937003612 aarcusa@cst.cat | |
| Principal Investigator: Maria Angeles Arcusa Lanza, MD | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Contact: Vanesa Ortega Cebrián, MD +34 934894350 vortega@vhebron.net | |
| Principal Investigator: Vanesa Ortega Cebrián, MD | |
| Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | |
| Girona, Spain, 17003 | |
| Contact: Sonia Del Barco Berron, MD +34 972225834 sdelbarco@iconcologia.net | |
| Principal Investigator: Sonia Del Barco Berron, MD | |
Sponsors and Collaborators
Institut Català d'Oncologia
Investigators
| Principal Investigator: | Beatriz Cirauqui Cirauqui, MD | Fundació Institut d'Investigació Germans Trias i Pujol | |
| Principal Investigator: | Sonia Del Barco Berron, MD | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | |
| Principal Investigator: | Vanesa Ortega Cebrián, MD | Hospital Vall d'Hebron | |
| Principal Investigator: | Maria Angeles Arcusa Lanza, MD | Consorci Sanitari de Terrassa | |
| Principal Investigator: | Antonio Agudo, MD | Institut Català d'Oncología - L'Hospitalet (ICO) |
| Responsible Party: | Institut Català d'Oncologia |
| ClinicalTrials.gov Identifier: | NCT02035631 |
| Other Study ID Numbers: |
PREDICOP |
| First Posted: | January 14, 2014 Key Record Dates |
| Last Update Posted: | January 14, 2014 |
| Last Verified: | January 2014 |
Keywords provided by Institut Català d'Oncologia:
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Breast Neoplasms Recurrence Motor Activity Diet Quality of Life |
Additional relevant MeSH terms:
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Breast Neoplasms Recurrence Neoplasms Disease Attributes |
Pathologic Processes Neoplasms by Site Breast Diseases Skin Diseases |