Physically Active During Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Patient reported peripheral sensory neuropathy
研究概览
简要总结
This randomized controlled trial aims to investigate whether an individually tailored exercise program and nutritional guide can affect the development of self-reported peripheral sensory neuropathy and fatigue in patients with colorectal cancer receiving adjuvant chemotherapy.
详细描述
Colorectal cancer is the second most common cancer in Norway with 4332 new cases in 2017. Standard of care is radical surgery followed by adjuvant chemotherapy for some, depending on the stage of the disease. Most commonly, a combination of Oxaliplatin and Capecitabine or 5-fluorouracil is given for 3 to 6 months.
A common side effect of Oxaliplatin is peripheral sensory neuropathy, which occur in different degree in over 90 % of the patients. There is no established treatment to prevent or reduce Oxaliplatin induced peripheral neuropathy. A few minor studies have been published indicating that physical activity can reduce the patient's experience of chemotherapy-induced peripheral neuropathy.
Most patients receiving chemotherapy will experience fatigue in some degree. It has been shown in several studies that exercise can reduce cancer related fatigue, though most studies have been performed among women with breast cancer.
There are a limited number of randomized controlled clinical trials looking at the effects of physical exercise during ongoing adjuvant chemotherapy in colorectal cancer patients. Thus, there is a clear need for further studies on physical exercise in this patient group.
In the period from January 2017 to November 2018 the investigators did a non-randomized pilot study to test the feasibility of the exercise intervention in this patient group, and to calculate sample size for the randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Radical resection for colon- or rectal cancer past 3 months, and scheduled for adjuvant, Oxaliplatin-based, combination chemotherapy.
- •Histologically confirmed adenocarcinoma.
- •Able to read and understand Norwegian.
- •Able to carry out the intervention.
- •Performance Status (PS) 0 - 2.
排除标准
- •Serious comorbidities that contraindicate physical exercise, based on the treating physician's assessment.
- •Unable to give informed consent.
- •Treated for other cancer last 5 years prior to inclusion (with the exceptions of basal cell carcinoma of the skin and carcinoma in situ in the cervix).
- •Prior treatment with Oxaliplatin
研究组 & 干预措施
Exercise training and nutritional guide
Standard recommendations regarding physical activity and nutrition. An individually tailored exercise program and nutritional guide during adjuvant chemotherapy.
干预措施: Standard follow-up care (Other)
Exercise training and nutritional guide
Standard recommendations regarding physical activity and nutrition. An individually tailored exercise program and nutritional guide during adjuvant chemotherapy.
干预措施: Exercise training and nutritional guide (Behavioral)
Standard follow-up care
Standard recommendations regarding physical activity and nutrition.
干预措施: Standard follow-up care (Other)
结局指标
主要结局
Patient reported peripheral sensory neuropathy
时间窗: Baseline to 3 months
The 9-item European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Chemotherapy Induced Peripheral Neuropathy (CIPN20) sensory subscale will be used to measure sensory neuropathy. Each item is rated on a scale from 1 ("not at all") to 4 ("very much"), and the total raw score ranges from 9 to 36. The raw scores will be linearly transformed to a 0 to 100 scale (higher scores represent worse CIPN severity).
次要结局
- Change in patient reported motor neuropathy(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Change in patient reported autonomic neuropathy(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Fatigue(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Change in patient reported peripheral sensory neuropathy.(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Clinicians reported neuropathy(Baseline to 3, 6 and 12 months.)
- Change in body mass index (BMI)(Baseline to 3, 6 and 12 months.)
- Change in systolic blood pressure (sBP)(Baseline to 3, 6 and 12 months.)
- Change in diastolic blood pressure (dBP)(Baseline to 3, 6 and 12 months.)
- Change in waist circumference.(Baseline to 3, 6 and 12 months.)
- Change in HDL-cholesterol(Baseline to 3, 6 and 12 months.)
- Change in Triglycerides(Baseline to 3, 6 and 12 months.)
- Change in Glycated hemoglobin (HbA1c)(Baseline to 3, 6 and 12 months.)
- Change in Glucose(Baseline to 3, 6 and 12 months.)
- Change in Body Composition(Baseline to 3 and 12 months)
- Nutritional status(Baseline, 1, 2, 3, 4, 5 and 6 months)
- Change in Quality Of Life: EORTC QLQ-C30 Version 3.0(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Completion of adjuvant treatment 1(3 to 6 months)
- Completion of adjuvant treatment 2(3 to 6 months)
- Completion of adjuvant treatment 3(3 to 6 months)
- Physical capacity(Baseline to 3, 6 and 12 months.)
- Self-reported physical activity(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Muscle strength(Baseline to 3, 6 and 12 months.)
- Balance 1(Baseline to 3, 6 and 12 months.)
- Balance 2(Baseline to 3, 6 and 12 months.)
- Haematological toxicity(Baseline to 6 months.)
- Time before return to work(Baseline to 3, 6, 9, 12, 24 and 36 months)
- Overall- and disease free survival(Baseline to 5 years)