Study of association between prakriti and outcomes of early and locally advanced breast cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- To evaluate the association between Prakriti and systemic therapy-related adverse events in early and locally advanced (non- metastatic) breast cancer patients
研究概览
简要总结
Chemotherapeutic drugs have been widely used in the treatment of breast cancer. Ayurveda defines that each person has a unique body constitution and has unique type of Prakriti. Can Ayurveda help us understand the correlation between variable outcomes of chemotherapeutics in different patients. Currently, there are only a handful of studies with respect to prakriti in the cancer domain; one case-control study of prakriti assessment in cancer patients is ongoing at TMH and CARI, where prakriti is being assessed in ovarian and cervical cancer patients along with healthy volunteers to study the association. In addition, recent studies also suggest that the composition of gut microbiome gets altered during various disease or treatment modalities, which govern the treatment outcomes. With this background information on the variable effects of chemotherapeutic drugs on different individuals due to genetic differences, the relationship between prakriti, the gut microbiome of an individual, and the correlation between individual gut microbiome composition and chemotherapeutic drug metabolism, it is logical to assess the correlation between prakriti and the effect of chemotherapy on systemic metabolomics and gut microbiome composition. The study aims to integrate the two medical sciences and analyze the connection between them using modern evidence-based scientific tools that may help determine personalized treatment regimens and pharmacodynamics and pharmacokinetics. Prakriti-based treatments may thus help change the existing healthcare situation.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •A.) Inclusion criteria for cancer patients for Prakriti assessment-
- •Adult females of age 18 years to 65 years
- •Patients who will receive AC or EC and paclitaxel chemotherapy as adjuvant or neoadjuvant therapy for breast cancer.
- •All subtypes of breast cancer (hormone receptor positive, TNBC and HER 2 positive disease)
- •ECOG PS 0 to 2
- •Adequate organ function
- •Patient willing to give written informed consent B.) Inclusion criteria for cancer patients for microbiome study:
- •ECOG PS 0-2
- •Patient willing to give written informed consent C.) Inclusion criteria for healthy volunteers:
- •Apparently healthy adult females of age 40 years to 65 years
- •Willing to give written informed consent.
排除标准
- •A.) Exclusion criteria for cancer patients:
- •Metastatic breast cancer
- •Patients suffering from psychological illness or taking medicine for psychological illness B.) Exclusion criteria for cancer patients for microbiome study:
- •History of severe gut disease (Malabsorption syndromes such as coeliac sprue, undergone gut resection) or other uncontrollable gastrointestinal conditions such as inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS)
- •Patients who were administered antibiotics/antivirals/antifungals for more than 10 days in the preceding 1 month of enrolment into the study
- •Patients who have recently used probiotics or laxatives (within 1 months)
- •Diabetic patients who are on oral Metformin will be excluded
- •Patients suffering from psychological illness or taking medicine for psychological illness C.) Exclusion criteria for healthy volunteers:
- •Administered antibiotics/antivirals/antifungals for more than 10 days in the preceding 1 month of enrolment into the study
- •Recently used probiotics or laxatives (within 1 month)
- •Patients suffering from psychological illness or taking medicine for psychological illness.
结局指标
主要结局
To evaluate the association between Prakriti and systemic therapy-related adverse events in early and locally advanced (non- metastatic) breast cancer patients
时间窗: Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle.
次要结局
- To evaluate the prognostic significance of prakriti in early and locally advanced breast cancer patients(Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle.)
- To study the association between prakriti and quality of life during the course of systemic therapy for early and locally advanced breast cancer patients
- To study the interaction between prakriti, gut microbiome and metabolome.(Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle.)
- Identify predictors of overall toxicity and survival outcomes(Baseline, after cycle 4 of AC/EC and paclitaxel and for every 6 months for 2 years post last chemotherapy cycle.)
研究者
Dr Vikram Gota
ACTREC, Tata Memorial Centre