Neurotoxicity Prevention With a Multimodal Program (ATENTO) Prior to Cancer Treatment Versus Throughout Cancer Treatment in Women Newly Diagnosed for Breast Cancer: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Quality of life (QLQ)
研究概览
简要总结
The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments.
详细描述
One of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system. Neurotoxicity is present in up to 75% of this population, which implies a large impact in quality of life. There is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae, whose benefits could improve thanks to the combination with vagal activation techniques.
This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention (ATENTO) based on moderate-high intensity and individualized therapeutic exercise (aerobic and strength exercises) and vagal activation techniques (myofascial stretching and breathing exercises), on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments (ATENTO-B) versus throughout them (ATENTO-T). A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85% will be allocated into two groups.
This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To have 18 years or older
- •To have a breast cancer diagnosis (Stage I-III)
- •To be on waiting list for medical adjuvant treatment with risk of central and/or peripheral neurotoxicity.
- •To have signed the informed consent.
- •To have medical clearance for participation.
排除标准
- •To have a previous history of cancer or any cancer treatment.
- •Pregnant patients.
- •To participate in another intervention that could influence on the outcomes.
- •To have a neurodegenerative disease that affects central or peripheral nervous system and could influence the results.
结局指标
主要结局
Quality of life (QLQ)
时间窗: Participants will be followed over 12 months
The primary outcome will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0, that is one of the most widely used instruments to measure quality of life in cancer patients.
次要结局
- Cognitive function: attention(Participants will be followed over 12 months)
- Cognitive function: memory and processing speed(Participants will be followed over 12 months)
- Presence of pain(Participants will be followed over 12 months.)
- Tactile sensation(Participants will be followed over 12 months)
- Intensity of symptoms(Participants will be followed over 12 months)
- Sleep disturbance(Participants will be followed over 12 months)
- Static body balance(Participants will be followed over 12 months)
- Subjective cognitive function(Participants will be followed over 12 months)
- Psychological diistress(Participants will be followed over 12 months)
- Cardiorespiratory fitness(Participants will be followed over 12 months)
研究者
Irene Cantarero Villanueva
Irene Cantarero Villanueva
Universidad de Granada