Actively Recruiting
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients
Led by University Institute of Maia · Updated on 2025-03-26
86
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University Institute of Maia
Lead Sponsor
A
Aveiro University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female gender
- Age 18 years or older
- Newly diagnosed histologically confirmed breast carcinoma stages IA to IIIC
- Planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, possibly with anti-HER2 drugs
- Followed by the oncology department of CHVNG/E
- Medical oncologist consents to physical exercise
- Able to provide written informed consent
- Accepts randomization to control or experimental group
You will not qualify if you...
- Previous cancer diagnosis
- Evidence of simultaneous other oncologic disease
- Physical or psychiatric contraindications to physical exercise
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centro Hospitalar Vila Nova Gaia e Espinho
Vila Nova de Gaia, Porto District, Portugal, 4434-502
Actively Recruiting
Research Team
N
Nuno D Rato, MSc
CONTACT
A
Alberto Alves, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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