EUCTR2016-002435-15-ES
Active, not recruiting
Phase 1
Pilot study to assess physical exercise intervention in neoadjuvant treatment with nab-paclitaxel in patients with triple negative breast cancer - OncoExer
Fundación de Investigación HM Hospitales0 sitesJune 9, 2017
DrugsAbraxane
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fundación de Investigación HM Hospitales
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.\- Women with TNBC stages II and III (A, B).
- •2\.\- Women \= 18 years old.
- •3\.\- Patients with a tumor size \= 2 cm, N0, N1\-2\.
- •4\.\- Patients able to start a physical exercise program (if randomized to that arm) in the same week that starting neoadjuvant chemotherapy.
- •5\.\- Patientes that dedicate \< 60 minutes of physical activity per week.
- •6\.\- Patients that declare to be not smokers/drinker at the time of diagnosis.
- •7\.\- Patients with Cholesterol value \<200 at the time of diagnosis.
- •8\.\- Patients No diagnosed with hyperthyroidism or hypothyroidism.
- •9\.\- No diagnosed with diabetes.
- •10\.\- Patients with an echocardiogram \> 50%.
Exclusion Criteria
- •1\.\- Patients with a history of chronic disease (Diabetes, not controlled high blood pressure, thyroid disease).
- •2\.\- Patients with a weight loss \>10% in the past 6 months.
- •3\.\- Patients with metastatic disease.
- •4\.\- Patients with cardiovascular, pulmonary or biomotor problems that might contraindicate physical exercise.
- •5\.\- Patients that declare to be smokers/drinker at the time of diagnosis.
- •6\.\- Patients with Cholesterol value \>200 at the time of diagnosis.
- •7\.\- Patients diagnosed with hyperthyroidism or hypothyroidism.
- •8\.\- Patients diagnosed with diabetes.
- •9\.\- Patients with an echocardiogram \< 50%.
- •10\.\- Patientes with additional treatments that might interfere with the current protocol.
Outcomes
Primary Outcomes
Not specified
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