NCT05976815 Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients
| NCT ID | NCT05976815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Institute of Maia |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2023-07-31 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. being female gender; 2. age equals or greater than 18 years old; 3. having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC; 4. planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs; 5. being followed by the oncology department of the CHVNG/E; 6. medical oncologists consents the practice of physical exercise; 7. the patient is capable of providing written informed consent; 8. the participant accepts to be allocated to the control or experimental group, according to the randomization. Exclusion Criteria: 1. previous cancer diagnostic; 2. evidence of synchronous oncologic disease; 3. physical or psychiatric contraindication to the practice of physical exercise.
Contact & Investigator
Nuno Rato, MSc
PRINCIPAL INVESTIGATOR
University of Maia
Frequently Asked Questions
Who can join the NCT05976815 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05976815 currently recruiting?
Yes, NCT05976815 is actively recruiting participants. Contact the research team at nuno.rato@umaia.pt for enrollment information.
Where is the NCT05976815 trial being conducted?
This trial is being conducted at Vila Nova de Gaia, Portugal.
Who is sponsoring the NCT05976815 clinical trial?
NCT05976815 is sponsored by University Institute of Maia. The principal investigator is Nuno Rato, MSc at University of Maia. The trial plans to enroll 86 participants.
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