About this trial
One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.
Eligibility criteria
Qualifiers
being female gender;
age equals or greater than 18 years old;
having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
Disqualifiers
previous cancer diagnostic;
evidence of synchronous oncologic disease;
physical or psychiatric contraindication to the practice of physical exercise.
Trial design
Treatments tested in this trial
- Combined Aerobic and Resistance Exercise
Treatment groups
Sponsors and collaborators
University Institute of Maia
Lead sponsor
Aveiro University
Collaborator
Centro Hospitalar de Vila Nova de Gaia/Espinho
Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Collaborator
University of Maia
Collaborator