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

NCT ID: NCT05976815

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2026-08-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Group

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.

Group Type: EXPERIMENTAL

Combined Aerobic and Resistance Exercise

Intervention Type: BEHAVIORAL

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.

Interventions

Combined 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aveiro University

OTHER

Sponsor Role: collaborator

Centro Hospitalar de Vila Nova de Gaia/Espinho

OTHER

Sponsor Role: collaborator

Associacao de Investigacao de Cuidados de Suporte em Oncologia

OTHER

Sponsor Role: collaborator

University of Maia

OTHER

Sponsor Role: collaborator

University Institute of Maia

OTHER

Sponsor Role: lead

Responsible Party

Alberto Alves

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nuno Rato, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Maia

Locations

Centro Hospitalar Vila Nova Gaia e Espinho

Vila Nova de Gaia, Porto District, Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Nuno D Rato, MSc

Role: CONTACT

nuno.rato@umaia.pt

+351 919985852

Alberto Alves, PhD

Role: CONTACT

ajalves@umaia.pt

Facility Contacts

Nuno Rato, MSc

Role: primary

nuno.rato@umaia.pt

+351919985852

Other Identifiers

keymove

Identifier Type: -

Identifier Source: org_study_id