Neuromuscular Deconditioning and Reconditioning in Colon Cancer Patients: A Pilot Study of an APA Muscle Rendorcement Program
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Acceptability of the program in terms of the number of sessions attended
研究概览
简要总结
Colon cancer is a real public health problem with more than 46,000 new cases diagnosed per year in France and about 650 cases in Burgundy. Muscle deconditioning (MD), which is characterized by a loss of muscle mass and function, is a frequent consequence in cancer patients and conditions the prognosis. Therefore, it is essential to understand its complex etiology in oncology in order to address the real need for therapeutic countermeasures in clinical practice. DM is a multifactorial process that is exacerbated by therapies. It induces neurogenic and muscular alterations that can profoundly affect patients' quality of life.
Currently, analyses of this phenomenon in oncology have been limited essentially to a global evaluation of physical performance, neglecting the muscular and nervous nature of the adaptations responsible for it.
Most studies analyzing the therapeutic effects of physical activity (PA) have shown numerous physiological and psychological benefits of aerobic exercise. However, this form of PA is still not very effective in preserving muscle mass.
Only muscle strengthening can have an anabolic effect by accelerating the rate of protein synthesis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria :
- •Adult patients who are < 80 years old
- •with a first diagnosis of colon cancer, regardless of TNM stage
- •to undergo a scheduled excision surgery (laparoscopic colectomy or laparoscopy)
- •with WHO stage < 1 to the inclusion visit
- •having given their written consent
- •living close to the participating center (<50 km)
- •ability to understand instructions
- •Criteria for inclusion of healthy subjects :
- •Adult who is < 80 years old
- •matched by gender, age and BMI to a patient
- •with WHO stage < 1 at visit V1
- •no medical contraindications to the program
- •having given written consent
排除标准
- •Criteria for exclusion of patients and healthy subjects :
- •Protected Adult
- •Person not affiliated to national health insurance
- •Pregnant or breastfeeding woman
- •uncontrolled hypertension
- •Suffers from unstable diabetes of any type
- •Suffers from heart disease. Pre-surgical VO2 test will confirm authorization.
- •Affected by any condition likely to complicate the performance of physical activity (neurological, psychiatric, neuromuscular disorders, severe osteoporosis)
- •Patient who received neo-adjuvant chemotherapy
- •Patient-specific exclusion criteria
- •Patient with rectal cancer or other evolving cancer
- •Exclusion criteria specific to healthy subjects
- •Subject has had cancer in the last 5 years
- •Subject with a high level of physical activity according to the IPAQ questionnaire
- •Criteria for exclusion of patients and healthy subjects for biopsy:
- •Person with keloidosis
- •Person with bleeding disorders, and/or on anticoagulant and antiaggregant medication
- •hypersensitivity to lidocaine
- •SECONDARY EXCLUSION CRITERIA FOR TRAINING PATIENTS
- •Patient with a WHO stage > 1 at the V2 visit
- •Presence of an ostomy (complicates PA practice)
- •absence of post-operative chemotherapy treatment
- •Refusal of the surgeon and/or oncologist and/or rehabilitation physician to practice PA SECONDARY EXCLUSION CRITERIA FOR HEALTHY SUBJECTS
- •subject with a WHO stage > 1 at the V2 visit
结局指标
主要结局
Acceptability of the program in terms of the number of sessions attended
时间窗: Up to Week 1 (evaluation 1) for healthy patients
Tolerance in terms of level of effort and pain will be tested at each session and will condition the continuation or not of the sessions and therefore acceptability
次要结局
未报告次要终点