OptiTrain - Optimal Training for Women With Breast Cancer During Chemotherapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Cancer related fatigue
研究概览
简要总结
This study on women with breast cancer during and after chemo- and hormonal therapy compares the effect of different physical training programs on physical and mental well-being and systemic inflammation mechanisms in blood. In a sub-group of participants, mitochondrial biogenesis and function and other molecular processes in skeletal muscle biopsies are studied. The women will be randomly allocated into three different intervention arms, a control arm with usual care and two different training arms. All participants will respond to questionnaires and have blood samples and taken and for a subgroup muscle biopsies before and after the exercise intervention. Participants will be supported to uphold exercise through collaboration with Friskis & Svettis and followed for 5 years. Some of the women will also be asked to participate in an in depth interview about the experiences of exercise during ongoing treatment. This study will contribute to increased knowledge about the type, intensity and frequency of training that patients with breast cancer benefit most from with regards to impact on physical and mental wellbeing. This knowledge is of great importance since experience shows that patients and relatives often seek information about rehabilitation, self-care and physical activity. The study will also contribute to the improvement of the patients´ quality of life, ability to return to work, and reduce social costs, but above all, increase the possibility for development and implementation of evidence-based rehabilitation of women with breast cancer during and after active treatment.
详细描述
Purpose The main aim is to, in women undergoing chemotherapy for breast cancer, explore how different training interventions impact physical capacity and psychological well being.
Research questions
- Does PA improve the ability to return to work after breast cancer treatment is completed?
- How do women with breast cancer during chemotherapy treatment respond to controlled and supervised aerobic fitness training and a combination of aerobic fitness training and strength training in physiological, structural and molecular outcome measures such as muscular strength, aerobic fitness, muscle mass, mitochondrial density, gene activity in muscle and B-Hb, s-CRP and other blood variables,?
- Is there a difference between the women in the aerobic exercise training group, the combined aerobic and strength-training group and the control group regarding symptom distress and health related quality of life?
- Are there any effects of exercise training on chemotherapy completion and hospitalization rates?
- Is adherence to physical exercise impacted by the individuals' personality?
- Are there any remaining effects of the physical exercise intervention, on cardiotoxicity, cognitive function, survival and morbidity, up to 5 years after treatment is completed?
- Is the intervention cost-effective?
Study design and methods Participants A total of 240 women will be recruited from the Department of Oncology Breast and Sarcoma units at Radiumhemmet and Södersjukhuset, Karolinska University Hospital.
Inclusion criteria: patients up to 70 years with breast cancer Stage I-IIIa before the start of chemotherapy. Exclusion criteria: patients with advanced disease, patients where physical activity is considered contraindicated because of medical reasons such as heart or lung disease, brain or bone metastases, cognitive dysfunction, and patients who do not speak or understand the Swedish language.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •patients up to 70 years with breast cancer Stage I-IIIa before the start of chemotherapy.
排除标准
- •patients with advanced disease, patients where physical activity is considered contraindicated because of medical reasons such as heart or lung disease, brain or bone metastases, cognitive dysfunction, and patients who do not speak or understand the Swedish language.
结局指标
主要结局
Cancer related fatigue
时间窗: Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline
Piper fatigue scale
次要结局
- Health Related Quality of Life(Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
- Symptoms(Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
- Pain sensitivity(Change from baseline to 16 weeks, 2 years and 5 years post baseline)
- Aerobic fitness(Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
- Muscle strength(Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
- Body mass(Change from baseline to 16 weeks, 1 year, 2 years, and 5 years post baseline)
- Inflammation parameters(Change from baseline to 16 weeks, and 1 year and 5 years post baseline)
- Concentration of Troponin and pro-BNP(Change from baseline to 16 weeks, and 1 year post baseline)
- Muscle cross sectional area(Change from baseline to 16 weeks)
- Mitochondrial function, gene activity(Change from baseline to 16 weeks)
- Sense of coherence(Baseline)
- Chemotherapy completion(Baseline to 16 weeks)
- Hospitalization(Baseline to 16 weeks)
- Blood concentrations(Baseline to 16 weeks)
- Quality adjusted life years(Baseline, 16 weeks, and 1 year post baseline)
- Amsterdam Cognition Scan(5 years post baseline)
- Presence of heart failure(5 years post baseline)
- Overall survival (OS)(8 years post baseline)
- Invasive breast cancer-free survival (IBCFS)(8 years post baseline)
- Breast cancer-specific survival (BCSS)(8 years post baseline)
- Breast cancer-free interval (BCFI)(8 years post baseline)
- Distant recurrence-free interval (DRFI)(8 years post baseline)
研究者
Yvonne Wengstrom
OCN, PhD, Professor of Nursing
Karolinska Institutet