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

University Institute of Maia

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Combined Aerobic and Resistance Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05976815

keymove

Details and patient eligibility

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.

Enrollment: 86 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Control Group

No Intervention group

Description:

The control group will receive neoadjuvant chemotherapy alone (standard of care).

Experimental Group

Experimental group

Description:

The experimental group will receive neoadjuvant chemotherapy (standard of care) in conjunction with an exercise intervention. The exercise intervention will be implemented concurrently for the full duration of the neoadjuvant chemotherapy treatment.

Treatment:

Behavioral: Combined Aerobic and Resistance Exercise