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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Pathologic Complete Response [Срок оценки: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.]

Вторичные конечные точки (12)

• Treatment Tolerance - clinically assessed. [Срок оценки: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
• Treatment Tolerance - patient reported. [Срок оценки: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
• Chemotherapy Relative Dose Intensity [Срок оценки: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
• Number of Chemotherapy Dose Reductions [Срок оценки: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
• Number of Chemotherapy Delays [Срок оценки: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
• Number of Chemotherapy Early Discontinuations [Срок оценки: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.]
• Percentage of Tumor Infiltrating Lymphocytes [Срок оценки: At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).]
• Percentage of Tumor Ki67 [Срок оценки: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
• Percentage of Cytotoxic T Cells on Peripheral Blood [Срок оценки: 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 [Срок оценки: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
• Percentage of T Helper Cells on Peripheral Blood [Срок оценки: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]
• Plasma IFN-gamma levels [Срок оценки: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Centro Hospitalar Vila Nova Gaia e Espinho — Vila Nova de Gaia

Идентификаторы

NCT: NCT05976815 · keymove

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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