Metabolic response of an integrative medicine protocol on female breast cancer patients: A prospective quasi experimental study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Changes in the metabolic response of tumor as per PET Response Criteria in Solid Tumors (PERCIST 1.0)
研究概览
简要总结
Breast cancer has become a major health crisis in India and globally. Despite the current available standard care the mortality and morbidity rate are raising. To address the metabolic aspect of the tumor a more holistic approach on overall health is required along with the standard care to reduce the cancer burden. Hence, a pragmatic Integrative protocol as been designed by group of doctors from different fields and intervened on patients to study its effectiveness on the metabolic response of the tumor. The study also aims to observe the survival rate and the quality of life with follow up of 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 aged 18 years and above with a biopsy proven diagnosis of breast cancer of any stage.
- •Also includes newly diagnosed cases as well as patients who have already undergone conventional, alternative or surgery (mastectomy / lumpectomy).
排除标准
- •Patients who have psychological or cognitive illness that prevent them from given consent.
结局指标
主要结局
Changes in the metabolic response of tumor as per PET Response Criteria in Solid Tumors (PERCIST 1.0)
时间窗: 3 months, 6 months and 12 months follow up
Changes in tumor biomarkers like CA 15.3, CEA & LDH
时间窗: 3 months, 6 months and 12 months follow up
次要结局
- Quality of life using Edmonton Symptom Assessment Scale (ESAS), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLQ-C30 and CPS(Survival rate)
研究者
Dr Pradeep M K Nair
Mirakle Integrated Health Centre