Adding physical exercise to chemotherapy for breast cancer treatment
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial
This study is testing if adding a structured exercise program to chemotherapy can help women with newly diagnosed breast cancer respond better to treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Institute of Maia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vila Nova de Gaia, Porto District) |
| Trial ID | NCT05976815 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a physical exercise intervention on the efficacy of neoadjuvant chemotherapy in women with newly diagnosed breast cancer. The study involves a randomized controlled design where participants will be assigned to either receive chemotherapy alone or chemotherapy combined with a structured exercise program. The primary goal is to evaluate the rate of pathologic complete response (pCR) between the two groups, while secondary outcomes will assess treatment tolerability, immune response, physical fitness, and quality of life. The trial aims to determine if exercise can enhance the effectiveness of chemotherapy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with newly diagnosed histologically confirmed breast carcinoma who are scheduled to receive neoadjuvant chemotherapy.
Not a fit: Patients with a history of previous cancer diagnoses or those with contraindications to physical exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While the specific combination of exercise and neoadjuvant chemotherapy is novel, preclinical studies have shown promise in exercise-induced tumor size reductions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vila Nova de Gaia, Porto District
- Centro Hospitalar Vila Nova Gaia e Espinho — Vila Nova de Gaia, Porto District, Portugal (Recruiting)
Study contacts
- Principal investigator: Nuno Rato, MSc — University of Maia
- Study coordinator: Nuno D Rato, MSc
- Email: nuno.rato@umaia.pt
- Phone: +351 919985852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.