Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •previous cancer diagnostic;
- •evidence of synchronous oncologic disease;
- •physical or psychiatric contraindication to the practice of physical exercise.
结局指标
主要结局
Pathologic Complete Response
时间窗: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.
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.
次要结局
- Percentage of Tumor Infiltrating Lymphocytes(At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).)
- Plasma Irisin Levels(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Plasma Decorin Levels(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Plasma Oncostatin M Levels(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Chemotherapy Relative Dose Intensity(From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.)
- Percentage of Natural Killer T Cells on Peripheral Blood(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Plasma SPARC levels(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Maximal Isometric Quadriceps Strength(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Number of Chemotherapy Dose Reductions(From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.)
- Number of Chemotherapy Early Discontinuations(From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.)
- 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.)
- Number of Chemotherapy Delays(From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.)
- Percentage of Tumor Ki67(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Percentage of T Helper Cells on Peripheral Blood(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Percentage of Cytotoxic T Cells on Peripheral Blood(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Distance traveled in the 10 meter-incremental shuttle walk test(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Health-Related Quality of Life(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Plasma TNF-alpha levels(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Plasma IFN-gamma levels(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Maximal METS reached during a cardiopulmonary exercise test(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Weekly time time spent in light, moderate and vigorous physical activities and sedentary behaviours.(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Total Body Skeletal Muscle Mass(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Number of repetitions performed in the 30 second sit-to-stand test(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Maximal Isometric Handgrip Strength(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Body Mass Index(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Total Body Weight(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
- Total Body Fat(At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).)
研究者
Alberto Alves
Principal Investigator
University Institute of Maia