Overweight or obese breast cancer patients Cancer
Conditions
Interventions
We will randomize overweight or obese patients into four intervention arms:
1. Dietary Intervention (DI)
2. Physical Activity Intervention (PAI)
3. Physical Activity And Dietary Intervention (PADI)
4
Sponsors
European Institute of Oncology (Italy)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 18 or older 2. Written informed consent obtained 3. Willing to be randomized to either group 4. Histological breast cancer diagnosis 5. BMI comprised between 25 and 40 kg/m2 6. Within one year/6 months of completion of main cancer treatment 7. Willing to wear the wrist-based activity monitor during the 6-month study period
Exclusion criteria
Exclusion criteria: 1. Unable to find transportation to the study location over the study period 2. Plan to move away from Lombardy or to be out of town for more than 3 weeks during the study period 3. Investigator does not approve participation in the study in case of: 3.1. History of heart condition, stroke, chest pain during activity or rest 3.2. Severe hypertension 3.3. Patient is unable to walk for exercise (self-report) 3.4. Symptoms of alcohol or substance dependence 3.5. Recent hip fracture, hip or knee replacement, spinal surgery or other orthopedic complications that would prevent optimal participation in the physical activities prescribed 4. Any other severe medical condition or advanced age impeding the patient to adhere at the planned study follow-up period 5. Participant already participates to a physical activity or diet intervention trial 6. Participant currently uses an activity monitor device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight (weight loss =5% of the baseline body weight) at the end of the 6-month intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures will be assessed along intervention including: 1. Maintain long-term weight control, measured at baseline, 6 months, 12 months and 24 months 2. Increase physical activity levels and reduce physical inactivity from baseline, measured at baseline, 6 months, 12 months and 24 months 3. Change in dietary intake (increase adherence to healthy diet from baseline), measured at baseline, 6 months and 24 months 4. Evaluate the effect of intervention on long-term breast cancer recurrence 5. Change in health status and quality of life, measured at baseline, 6 months, 12 months and 24 months 6. Evaluate the effect of intervention on blood lipid profile (total cholesterol, LDL and HDL cholesterol, triglycerides), measured at baseline, 6 months and 24 months 7. Evaluate the effect of intervention on biomarkers (estradiol, C-reactive protein (CRP), insulin, glucose), measured at baseline, 6 months and 24 months | — |
Countries
Italy
Contacts
Public ContactPatrizia Gnagnarella
Outcome results
None listed