E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Supervised exercise regimen given during neoadjuvant chemotherapy for triple negative breast cancer patients. |
Ejercicio físico supervisado durante el tratamiento de quimioterapia neoadyuvante para pacientes con cáncer de mama triple negativo. |
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E.1.1.1 | Medical condition in easily understood language |
Supervised exercise regimen given during neoadjuvant chemotherapy for triple negative breast cancer patients. |
Ejercicio físico supervisado durante el tratamiento de quimioterapia neoadyuvante para pacientes con cáncer de mama triple negativo. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
El objetivo principal de este estudio es analizar el efecto de un programa de actividad física supervisada, en combinación con tratamiento neoadjuvante con nab-paclitaxel y carboplatino, en pacientes con cáncer de mama triple negativo, sobre calidad de vida, perfil metabolómico en sangre periférica y, finalmente, en la tasa de respuesta patológica completa. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
- Analizar e identificar los cambios en el perfil metabolómico de pacientes con cáncer de mama triple negativo a los que se les sugiere un régimen de ejercicio durante un tratamiento de quimioterapia neoadyuvante.
- Evaluar la calidad de vida de los pacientes con cáncer de mama triple negativo a los que se les sugiere un régimen de ejercicio durante un tratamiento de quimioterapia neoadyuvante.
- Determinar un grupo de metabolitos que deberían correlacionarse con el desempeño del cuestionario EORTC-QLQ-C30 y los parámetros clínicos relacionados con la respuesta a tratamiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1.- Mujeres con TNBC estadío II a III (A,B)
2.- Mujeres > 18 años
3.- Pacientes con tamaño de tumor > 2cm, N0, N1-2
4.- Pacientes con capacidad de empezar un programa de ejercicio físico (si se randomiza para esa rama) en la misma semana que se empieza quimioterapia neoadjuvante.
5.- Pacientes que dedican < 60 minutos a la semana a realizar actividad física.
6.- Pacientes que declaran ser no fumadores/bebedores durante el diagnóstico.
7.- Pacientes con colesterol <200 en el momento del diagnóstico.
8.- Pacientes no diagnosticados para hipertiroidismo o hipotiroidismo.
9.- No diabéticos
10.- Pacientes con ecocardiograma > 50%.
11.- Índice masa corporal entre 18,5 y 25.
12.- Que no tengan tratamientos adicionales que puedan interferir con el protocolo.
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E.4 | Principal 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. |
1.- Pacientes con historia clínica de enfermedad crónica (Diabetes, presión arterial alta no controlada, enfermedad tiroidea).
2.- Pacientes con pérdida de peso > 10% en los último 6 meses.
3.- Pacientes con enfermedad metastásica.
4.- Pacientes con problemas cardiovasculares, pulmonares o biomotores, que estén contraindicados con ejercicio físico.
5.- Pacientes que declaren ser fumadores/bebedores en el momento del diagnóstico
6.- Pacientes con colesterol >200
7.- Pacientes con hipertiroidismo e hipotiroidismo
8.- Pacientes con diabetes
9.- Pacientes con ecocardiograma < 50%
10.- Pacientes con otros tratamientos que puedan interferir con el protocolo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Study results and publications. |
- Resultados del estudio y publicaciones. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Recruitments of patients.
- End of treatment.
- Metabolomic Analysis. |
- Reclutamiento de pacientes
- Fin del tratamiento
- Análisis metabolómico
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Recruitments of patients --> September 2017.
- End of treatment --> May 2018.
- Metabolomic Analysis --> November 2018. |
- Reclutamiento de pacientes- Septiembre 2017
- Fin del tratamiento-Mayo 2018
- Análisis Metabolómico- Noviembre 2018
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Supervised Exercise regimen |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |