Effect of exercise training on the inflammatory profile in patients with breast cancer undergoing chemotherapy: an open label randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is an open label single centered randomized controlled trial to determine the effect of exercise training on the inflammatory profile of patients with breast cancer undergoing chemotherapy -anthracycline and cyclophosphamide regimen, when compared to patients who are on treatment without any exercise intervention. A total of 60 patients will be recruited for the study and randomized into intervention and control groups.The primary outcome will be inflammatory markers like TNF-a, CRP which will be investigated at the baseline -before chemotherapy, at the middle of chemotherapy treatment cycles and at the end of chemotherapy cycles. The secondary outcome will be body composition, muscle strength, quality of life, investigated at the baseline, at the middle of chemotherapy treatment cycles and at the end of chemotherapy cycles and other outcomes like treatment toxicity and relative dose intensity will be investigated after each cycle of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- Female
入选标准
- •Female patients who are diagnosed with breast cancer (Stage 1 to stage 3) and about to undergo neoadjuvant or adjuvant chemotherapy (cyclophosphamide-anthracycline regimen).
- •Normal cardiovascular, hepatic and renal function.
- •Patients who are willing to participate.
排除标准
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status more than
- •Currently with any musculoskeletal disturbances, severe respiratory illness, autoimmune diseases.
- •Patients who are pregnant.
- •Who had undergone major surgeries within past 3 months Known case of any psychiatric disorders, intellectual disabilities.
- •Under regular moderate to high intensity exercise (after calculation of physical activity level (PAL).
- •Receiving chronic anti-inflammatory medications for other diseases.
研究者
Dr Rose Babu
Jubilee Mission Medical College and Research Institute
