APACAN study_Adaptated Physical Activity in Cancerology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.
研究概览
简要总结
This trial will measure the fatigue in breast cancer patients.
Two groups of patients will be realised:
- Arm A: Physical activity during treatment
- Arm B: No physical activity during treatment but after
The aim of the study is to decrease fatigue, with adequate physical activity, in primary breast cancer patients who receive a treatment for their pathology.
详细描述
This is an open monocentric study, randomized in two parallel arms with a waiting list.
The duration of the physical activty will vary according to the duration of the treatment: from 2 to 6 months.
Several questionnaries (fatigue, quality of life, ...) will be given to patients at the inclusion, at the end of the period of treatment and 3 to 6 months after the end of treatment.
One hundred patients are necessary in this study (fifty in each arm). We expect to a stability of the fatigue in Arm A compared to an increase of the fatigue in arm B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 75 years (included)
- •Patient with a breast tumor, regardless of the stage and size (except metastatic patients)
- •Patient with a local recurrence of breast cancer
- •Patient with a second non-metastatic breast cancer
- •Breast cancer treated, regardless of the surgery, at least by radiotherapy, chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy
- •A mandatory social security affiliation.
- •Obtaining informed consent in writing, signed and dated.
- •Medical certificate of fitness to practice physical (issued by the medical oncologist)
排除标准
- •Cancer other than breast cancer and / or associated with breast cancer
- •Metastatic Cancer
- •in case of surgery before treatment, delay before beginning treatment inferior to 1 month post-surgery
- •Woman pregnant
- •Patient with cognitive or psychiatric disorders
- •Patients suffering from disability
- •Significant alterations in nutritional status (malnutrition with BMI <19, obese with BMI> 40, BMI)
- •Cardiac contraindication to physical activity
- •Knowledge and understanding of the French language enough not to learn the correct way of self-administered questionnaires or respond to questioning
- •Participation in another clinical study with a similar objective
- •Inability to reach the centers where physical activity takes place
结局指标
主要结局
Difference between the questionnaries scores MFI 20 (specific fatigue) between baseline and end of treatment.
时间窗: up to 6 months
The scores of fatigue at the end of treatment and at the inclusion will be compared.
次要结局
- QLQ-C30(up to 6 months)