RecruitingNot ApplicableNCT05976815

Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients

Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial


Sponsor

University Institute of Maia

Enrollment

86 participants

Start Date

Jul 31, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a structured physical exercise program to chemotherapy before breast cancer surgery (neoadjuvant chemotherapy) improves the cancer's response to treatment compared to chemotherapy alone. **You may be eligible if...** - You are a woman aged 18 or older - You have been newly diagnosed with breast cancer (stage IA–IIIC) confirmed by biopsy - You are planned to receive neoadjuvant chemotherapy (with anthracyclines or taxanes), which may also include HER2-targeted drugs - Your oncologist approves your participation in an exercise program - You are treated at the relevant hospital and able to provide written consent **You may NOT be eligible if...** - You have a previous cancer diagnosis - You have another cancer at the same time - You have a physical or psychiatric condition that prevents you from safely exercising Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCombined Aerobic and Resistance Exercise

Apart from the neoadjuvant chemotherapy treatment (standard of care), participants allocated to the experimental group will additionally participate in a supervised physical exercise program that comprises 3 weekly sessions during the months that the patient is undergoing chemotherapy treatment. Each 75-minute session will comprise a 10-minute warm up, 30 minutes of strength training involving exercise for the major muscle groups, 30 minutes of aerobic training at 40-89% of heart rate reserve and a 5-minute cool down.


Locations(1)

Centro Hospitalar Vila Nova Gaia e Espinho

Vila Nova de Gaia, Porto District, Portugal

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NCT05976815


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