Physical Activity for Reduction of Recurrence Rate After Adjuvant Chemotherapy for Localised Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Feasibility of Physical Activity After 12 Weeks (3 Months)
研究概览
简要总结
- feasibility of physical activity
- increase of physical conversation
- Quality of Life (optional)
- vascular and metabolic effects
详细描述
In this phase II pilot project the feasibility of a defined medical physical activity should be verified for increased physical conversation. The study is conducted multicentric (single group) with a study population of 30 patients. After completion of adjuvant chemotherapy the patients will participate a defined physical training, 3 times per week within a time period of 52 weeks. Planned study duration 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •complete resected, histologically confirmed adeno carcinoma of colon or rectal and condition after (neo-)adjuvant therapy either in (1) stage III or (2) stage II with risk factor
- •4-16 weeks after the end of an adjuvant chemotherapy
- •Age > 18 years
- •adequate liver-, nephro- and hemogram parameters
- •physical eligibility
排除标准
- •significant comorbidities which exclude the participation
- •evidence of local recurrence or distant metastases
- •non-compliance of subject
- •other malignancy within the last 5 years (except: skin basalioma, cervix carcinoma in situ)
- •clinically significant cardiovascular diseases
- •treatment with beta blocker without possibility of adjustment
- •left bundle-branch block
- •simultaneous chemotherapy or radiotherapy
- •pregnancy
结局指标
主要结局
Feasibility of Physical Activity After 12 Weeks (3 Months)
时间窗: 3 months
Evaluation of the feasibility measured in terms of training adherence during the first 12 weeks measured in actual participant-weeks in relation to the 360 planned participant-weeks during cycle 1 (week 1 to week 12)
Feasibility of Physical Activity After 26 Weeks (6 Months)
时间窗: 6 months
Evaluation of the feasibility measured in terms of training adherence during the weeks 13 to 26 measured in actual participant-weeks in relation to the planned 420 participant-weeks during cycle 2 (week 13 to week 26)
Feasibility of Physical Activity After 52 Weeks (12 Months)
时间窗: 12 months
Evaluation of the feasibility measured in terms of training adherence during the weeks 27 to 52 measured in actual participant-weeks in relation to the planned 780 participant-weeks during cycle 3 (week 27 to week 52)
次要结局
- Exercise Ergometry Activity After 12 Weeks (3 Months)(3 months)
- Exercise Ergometry Activity After 26 Weeks (6 Months)(6 months)
- Exercise Ergometry Activity After 52 Weeks (12 Months)(12 months)
- Adiponectin at Screening(Day 1 (at screening))
- Adiponectin After 12 Weeks (3 Months)(3 months)
- Adiponectin After 52 Weeks (12 Months)(12 months)
- Leptin at Screening(Day 1 (at screening))
- Leptin After 12 Weeks (3 Months)(3 months)
- Leptin After 52 Weeks (12 Months)(12 months)