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

NCT05976815 | Recruiting

• 1 other identifier: keymove
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; Neoadjuvant Chemotherapy; Physical Exercise; Pathologic Complete Response; Immune System

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response

  Pathological response as the primary outcome will be assessed by a blinded pathologist from the tumour surgical specimens after the breast surgery (post-intervention) and will be defined as complete, partial or no response. Besides pathological complete response (defined as ypT0/ypN0), groups will be compared as those with response (complete or partial) versus those with no response. The residual cancer burden which quantifies residual disease after NAC (post-intervention) will also be assessed.

  Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.

Secondary Outcomes (28)

• Treatment Tolerance - clinically assessed.

  From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.

• Treatment Tolerance - patient reported.

  From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.

• Chemotherapy Relative Dose Intensity

  From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.

• Number of Chemotherapy Dose Reductions

  From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.

• Number of Chemotherapy Delays

  From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.

Study Arms (2)

Control Group

NO INTERVENTION

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

Experimental Group

EXPERIMENTAL

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.

Behavioral: Combined Aerobic and Resistance Exercise

Interventions

Combined Aerobic and Resistance Exercise 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being female gender;
• age equals or greater than 18 years old;
• having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
• planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
• being followed by the oncology department of the CHVNG/E;
• medical oncologists consents the practice of physical exercise;
• the patient is capable of providing written informed consent;
• the participant accepts to be allocated to the control or experimental group, according to the randomization.

You may not qualify if:

• previous cancer diagnostic;
• evidence of synchronous oncologic disease;
• physical or psychiatric contraindication to the practice of physical exercise.

Sponsors & Collaborators

• University Institute of Maia: lead
• Aveiro University: collaborator
• Centro Hospitalar de Vila Nova de Gaia/Espinho: collaborator
• Associacao de Investigacao de Cuidados de Suporte em Oncologia: collaborator
• University of Maia: collaborator

Study Sites (1)

Centro Hospitalar Vila Nova Gaia e Espinho

Vila Nova de Gaia, Porto District, 4434-502, Portugal

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nuno Rato, MSc

  University of Maia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuno D Rato, MSc

CONTACT

+351 919985852; nuno.rato@umaia.pt

Alberto Alves, PhD

CONTACT

ajalves@umaia.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: August 4, 2023
• Study Start: July 31, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)