The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity
研究概览
简要总结
Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.
详细描述
The scientific goals of the project are:
- The primary scientific objective of the study is to determine the effect of a patient-tailored exercise program based on exercise guidelines in oncology on sensory symptoms of CIPN (QLQ-CIPN20, sensory subscale) at short term (12 weeks) compared to usual care.
- The secondary scientific objectives entail to examine if the exercise program has beneficial short (i.e., 12 weeks) and- or long term (i.e., 24 weeks) effects on symptoms of CIPN (QLQ-CIPN20, motor and autonomic subscale) and other biopsychosocial outcomes related to CIPN: (1) Signs of CIPN, (2) Physical functioning, (3) Psychosocial functioning, and (4) Relative dose intensity of chemotherapy.
- The tertiary objective of this study is to perform a process evaluation. The aim of this process evaluation is to investigate the barriers and facilitators of the exercise program in patients receiving taxane- or platinum-based chemotherapy by examining adherence to the exercise program as well as how patients and healthcare providers perceive the implementation of the exercise program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age above 18 years
- •a primary diagnosis of breast, gynaecological or colon cancer, without distant metastasis
- •been chemotherapy naïve
- •been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy
排除标准
- •life expectancy of less than six months according to the patient's oncologist or designee
- •advanced stage of disease
- •having a known current neuropathy
- •having cognitive or physical limitations that contraindicate participation in a low- to moderate intensity home-based walking and progressive resistance program (determined by the patient's oncologist)
- •not able to read and understand Dutch
- •not able to provide informed consent
- •not able to participate during the entire study period
- •pregnancy
研究组 & 干预措施
Exercise intervention
Participants receive a 12-week individually tailored exercise program from the start of taxane- or platinum-based chemotherapy, in addition to the standard of care (advice on physical activity during cancer treatment)
干预措施: Exercise intervention (Behavioral)
No formal exercise intervention
Standard of care (advice on physical activity during cancer treatment)
结局指标
主要结局
Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity
时间窗: at 12 weeks follow-up
To evaluate the primary outcome sensory symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20 sensory subscale, score range from 9 to 36, higher scores indicating more sensory symptoms or problems).
次要结局
- Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity(at 4, 8, 12 and 24 weeks follow-up)
- Relative dose intensity chemotherapy (%)(at 4, 8, 12 and 24 weeks follow-up)
- Chemotherapy-induced peripheral neuropathy (CIPN) signs(at 12 and 24 weeks follow-up)
- Pain severity hands and feet(at 12 and 24 weeks follow-up)
- General pain location and interference(at 12 and 24 weeks follow-up)
- Physical functioning(at 12 and 24 weeks follow-up)
- Self-reported physical activity(at 12 and 24 weeks follow-up)
- Objective physical activity(at 12 and 24 weeks follow-up)
- Fatigue(at 12 and 24 weeks follow-up)
- Sleep disturbance(at 12 and 24 weeks follow-up)
- Depression(at 12 and 24 weeks follow-up)
- Anxiety(at 12 and 24 weeks follow-up)
- Social participation(at 12 and 24 weeks follow-up)
- Support(at 12 and 24 weeks follow-up)
- Cognitive function(at 12 and 24 weeks follow-up)
- Health-related quality of life(at 12 and 24 weeks follow-up)