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Clinical Trials/EUCTR2016-002435-15-ES
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

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.

Registry
who.int
Start Date
June 9, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Fundación de Investigación HM Hospitales

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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