Supervised exercise regimen given during neoadjuvant chemotherapy for triple negative breast cancer patients.
Conditions
Interventions
Trade Name: Abraxane
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Nab-paclitaxel
CAS Number: 33069-62-4
Other descriptive name: PACLITAXEL ALBUMIN-BOUND
C
Sponsors
Fundación de Investigación HM Hospitales
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to compare the circulating metabolites of TNBC patients suggested to supervised exercise regimen given during neoadjuvant chemotherapy (150 min/week) versus a control group with normal physical activity, both treated with neoadjuvant weekly nab-paclitaxel plus weekly carboplatin.;Secondary Objective: - To analyse and identify changes on the metabolomic profile of TNBC patients suggested to supervised exercise regimen given during neoadjuvant chemotherapy. - To evaluate the Quality of Life of TNBC patients suggested to supervised exercise regimen given during neoadjuvant chemotherapy. - To determine a group of metabolites that might be correlated with the EORTC-QLQ-C30 questionnaire performance and clinical parameters related to response to treatment.;Primary end point(s): - Study results and publications.;Timepoint(s) of evaluation of this end point: April 2019. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Recruitments of patients. - End of treatment. - Metabolomic Analysis.;Timepoint(s) of evaluation of this end point: - Recruitments of patients --> September 2017. - End of treatment --> May 2018. - Metabolomic Analysis --> November 2018. | — |
Countries
Spain
Contacts
Public ContactFundación de Inv. HM Hospitales
Fundación de Investigación HM Hospitales
Outcome results
None listed