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Recruiting NCT05976815

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Combined Aerobic and Resistance Exercise.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral 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 an

Primary outcome measures

  • Pathologic Complete Response [Time frame: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.]
Secondary outcome measures (12)
  • Treatment Tolerance - clinically assessed. [Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
  • Treatment Tolerance - patient reported. [Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
  • Chemotherapy Relative Dose Intensity [Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
  • Number of Chemotherapy Dose Reductions [Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
  • Number of Chemotherapy Delays [Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
  • Number of Chemotherapy Early Discontinuations [Time frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
  • Percentage of Tumor Infiltrating Lymphocytes [Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).]
  • Percentage of Tumor Ki67 [Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
  • Percentage of Cytotoxic T Cells on Peripheral Blood [Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
  • Percentage of Natural Killer T Cells on Peripheral Blood [Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
  • Percentage of T Helper Cells on Peripheral Blood [Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
  • Plasma IFN-gamma levels [Time frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Portugal · 1 center
  • Centro Hospitalar Vila Nova Gaia e Espinho — Vila Nova de Gaia

Identifiers

NCT: NCT05976815 · keymove

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗