Testicular Cancer and Aerobic and Strength Training - a Randomized Controlled National Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- VO2peak (directly by modified Balke protocol on a treadmill)
研究概览
简要总结
The present study examine the effects of an aerobic and strength training program on cardiorespiratory fitness in testicular cancer (TC) patients during chemotherapy. Half of the participants will receive the exercise program and the other half will receive one individual lifestyle counseling session. The investigators hypothesize that TC patients in the exercise group will have less reduction in cardiorespiratory fitness during chemotherapy treatment compared to patients in the control group.
详细描述
Testicular cancer (TC) patients receiving chemotherapy often experience troublesome side-effects during and after treatment. Both aerobic and strength exercise have showed beneficial effects on side-effects during and after treatment in other cancer diagnosis. Knowledge of the effects of physical exercise during and after chemotherapy in TC patients is insufficient and studies are needed. The primary aim is to examine the effects of physical exercise on cardiorespiratory fitness in TC patients during chemotherapy. Secondary aims are to examine the effects of physical exercise on other secondary health outcomes during and three and twelve months after chemotherapy.
The present study is a randomized controlled trial comparing a tailored exercise program consisting of aerobic and strength training during chemotherapy to a control group receiving one individual lifestyle counseling session during the first chemotherapy cycle. The TC patients will be included and assessed before the first cycle of chemotherapy and further assigned to either a exercise group or a control group. The intervention will last for 9 or 12 weeks (depending on the number of bleomycin, etoposide, cisplatin (BEP)/etoposide, cisplatin (EP) cycles received) and it will consists of two-three one-hour sessions per week mostly supervised by a personal trainer. All variables will be assessed pre- and post-intervention, and at three and 12 months follow-up.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •testicular cancer with seminoma or non-seminoma
- •stage II-IV
- •referred to chemotherapy (3-4 BEP (bleomycin, etoposide and cisplatin)-cycles or 4 EP (etoposide and cisplatin) -cycles) with/without retroperitoneal lymph node dissection (RPLND)
- •satisfactory Norwegian Language skills
- •signed informed consent
排除标准
- •severe brain and lung metastasis (reduced lung function)
- •heart and lung diseases that contraindicate exercise testing and the supervised exercise program without adjusted actions according to American College of Sports Medicine (ACSM)'s guidelines)
- •physical and mental conditions of a severity that complicates the ability for exercise testing and the supervised exercise program
结局指标
主要结局
VO2peak (directly by modified Balke protocol on a treadmill)
时间窗: Pre-intervention (week 0) to post-intervention (week 10/13)
Differences in change in VO2peak from pre- to post-intervention between the exercise group and the control group.
次要结局
- Body mass index (BMI)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Hip- and Waist circumferences(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C-30(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- VO2peak (directly by modified Balke protocol on a treadmill)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- One-repetition maximum muscle strength test (1RM)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Hospital and Anxiety and Depression Scale (HADS)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Safety and tolerability(Pre-intervention (week 0) to post-intervention (week 10/13))
- Sick leave and Work Ability Index (WAI)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Markers for inflammation, endothelia dysfunction, thrombosis and cardiovascular diseases and cisplatin(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Spirometry(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Dual-energy X-ray absorptiometry (DXA)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Godin Leisure Time Exercise Questionnaire (GLTEQ)(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
- Fatigue questionnaire(Pre-intervention (week 0) to post-intervention (week 10/13) and at three and 12 months follow-ups)
研究者
Lene Thorsen
PhD
Oslo University Hospital