Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting
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
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 complian |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | University Institute of Maia |
| Locations | Vila Nova de Gaia, Porto District, Portugal |
| Start date | 2023-07-31 |
| NCT ID | NCT05976815 |
| Official listing | https://clinicaltrials.gov/study/NCT05976815 |