Pilot study to assess physical exercise intervention in neoadjuvant treatment with nab-paclitaxel in patients with triple negative breast cáncer

Phase 1

• Conditions: Supervised exercise regimen given during neoadjuvant chemotherapy for triple negative breast cancer patients.; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002435-15-ES
• Lead Sponsor: Fundación de Investigación HM Hospitales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-09
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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%.
11.- Bone mass index between 18,5 and 25.
12.- No additional treatments that might interfere with the current protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified