University Hospital Centre for Nursing and Care Research, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.
BMC Cancer. 2011 Aug 1;11:326. doi: 10.1186/1471-2407-11-326.
Standard treatment for patients with disseminated germ cell tumors is combination chemotherapy with bleomycin, etoposide and cisplatin (BEP). This treatment is highly effective, but the majority of patients experience severe adverse effects during treatment and are at risk of developing considerable long-term morbidity, including second malignant neoplasms, cardiovascular disease, and pulmonary toxicity. One neglected side effect is the significant muscular fatigue mentioned by many patients with testicular cancer both during and after treatment. Very limited information exists concerning the patho-physiological effects of antineoplastic agents on skeletal muscle. The primary aim of this study is to investigate the effects of BEP-treatment on the skeletal musculature in testicular cancer patients, and to examine whether the expected treatment-induced muscular deterioration can be attenuated or even reversed by high intensity progressive resistance training (HIPRT).
DESIGN/METHODS: The PROTRACT study is a randomized controlled trial in 30 testicular cancer patients undergoing three cycles of BEP chemotherapy. Participants will be randomized to either a 9-week HIPRT program (STR) initiated at the onset of treatment, or to standard care (UNT). 15 healthy matched control subjects (CON) will complete the same HIPRT program. All participants will take part in 3 assessment rounds (baseline, 9 wks, 21 wks) including muscle biopsies, maximum muscle strength tests, whole body DXA scan and blood samples.
mean fiber area and fiber type composition measured by histochemical analyses, satellite cells and levels of protein and mRNA expression of intracellular mediators of protein turnover.
maximum muscle strength and muscle power measured by maximum voluntary contraction and leg-extensor-power tests, body composition assessed by DXA scan, and systemic inflammation analyzed by circulating inflammatory markers, lipid and glucose metabolism in blood samples. Health related Quality of Life (QoL) will be assessed by validated questionnaires (EORTC QLQ-C30, SF-36).
This study investigates the muscular effects of antineoplastic agents in testicular cancer patients, and furthermore evaluates whether HIPRT has a positive influence on side effects related to chemotherapy. A more extensive knowledge of the interaction between cytotoxic-induced physiological impairment and exercise-induced improvement is imperative for the future development of optimal rehabilitation programs for cancer patients.
Current Controlled Trials ISRCTN32132990.
对于患有播散性生殖细胞肿瘤的患者，标准治疗方法是博来霉素、依托泊苷和顺铂（BEP）联合化疗。这种治疗方法非常有效，但大多数患者在治疗过程中会出现严重的不良反应，并有发生严重长期发病率的风险，包括第二恶性肿瘤、心血管疾病和肺毒性。一个被忽视的副作用是许多睾丸癌患者在治疗期间和治疗后都提到的显著肌肉疲劳。关于抗肿瘤药物对骨骼肌的病理生理影响，信息非常有限。本研究的主要目的是研究 BEP 治疗对睾丸癌患者骨骼肌的影响，并研究高强度渐进性抗阻训练（HIPRT）是否可以减轻甚至逆转预期的治疗引起的肌肉恶化。
设计/方法：PROTRACT 研究是一项针对 30 名接受三个周期 BEP 化疗的睾丸癌患者的随机对照试验。参与者将被随机分配到治疗开始时启动的 9 周 HIPRT 方案（STR）或标准护理（UNT）组。15 名健康匹配的对照受试者（CON）将完成相同的 HIPRT 方案。所有参与者将参加 3 次评估轮次（基线、9 周、21 周），包括肌肉活检、最大肌肉力量测试、全身 DXA 扫描和血液样本。
通过组织化学分析测量平均纤维面积和纤维类型组成、卫星细胞以及细胞内蛋白质代谢调节剂的蛋白质和 mRNA 表达水平。
通过最大自主收缩和腿伸肌力量测试测量最大肌肉力量和肌肉力量，通过 DXA 扫描评估身体成分，通过循环炎症标志物、血液样本中的脂质和葡萄糖代谢分析系统性炎症，通过经过验证的问卷（EORTC QLQ-C30、SF-36）评估健康相关生活质量（QoL）。
本研究调查了睾丸癌患者中抗肿瘤药物的肌肉影响，此外还评估了 HIPRT 是否对与化疗相关的副作用有积极影响。更广泛地了解细胞毒性引起的生理损伤与运动引起的改善之间的相互作用，对于未来为癌症患者开发最佳康复方案至关重要。
当前对照试验 ISRCTN32132990。
