Characterization of gut dysbiosis in Gastrointestinal Malignancies and exploration of probiotics supplementation on therapeutic outcome in patients receiving chemoradiation in these malignancies.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival.
研究概览
简要总结
Summary
Rationale:
There has been growing attention to study the impact of probiotics supplementation on treatment outcome of various cancers. It is based on the assumption that probiotics normalize the underlying dysbiosis which is linked to particular cancer. Incidence of GI malignancies including esophagus, colon and anal canal cancers is increasing worldwide and dysbiosis is one of the factors under investigation linked to the etiopathogenesis of these malignancies. Impact of probiotics on treatment outcomes of chemoradiation is under investigation. Therefore, it is pertinent to study how probiotics impacts treatment outcomes in GI cancer patients.
Novelty:
· The use of RCTs in evaluating probiotics on treatment outcome of chemoradiation in four GI malignancies.
· Metagenomics approaches to characterize the gut dysbiosis related to specific cancer.
Objectives:
1. To characterize gut microbiota dysbiosis and its clinical correlation in esophagus, colon, rectum and anal canal cancer patients.
2. To investigate the impact of probiotics supplementation on the chemoradiotherapy induced toxicities in esophagus, colon, rectum and anal canal cancer patients.
3. To assess the impact of probiotics supplementation on response of chemoradiation in patients with esophagus, colon, rectum and anal canal malignancies.
Methods:
The study includes 4 separate RCTs to evaluate the efficacy of probiotics in patients with GI malignancies. The end point of the study will be response rate, survival outcomes and safety & tolerability of treatment related toxicities.
Expected outcome:
The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Biopsy proven cases of inoperable cases of carcinoma esophagus in which definitive chemoradiation is planned.
- •Biopsy proven cases of carcinoma colon.
- •Patient who have completed radical surgery in the form of hemi colectomy.
- •Patient in whom adjuvant chemotherapy is planned.
- •Biopsy proven cases of carcinoma rectum in which neoadjuvant chemoradiation is planned before definitive surgery.
- •Biopsy proven cases of carcinoma anal canal in which definitive chemoradiation is planned.
- •Karnofsky Performance Status KPS greater than 60 percent.
排除标准
- •Patients who refuse to give their consent.
- •Serious co morbid diseases.
- •Post op patients.
- •History of any prior cancer, or coexisting tumours.
- •Patients with Immunity diseases Autoimmunity or Immunodeficiency.
- •Prior GI toxicities
- •Prior history of radiotherapy administration.
- •Prior probiotics or oral antibiotics intake within 15 days.
- •Metastatic disease.
结局指标
主要结局
The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival.
时间窗: 04 years
次要结局
- The metagenomics approaches will help to gain insights into the functional potential of the gut microbiota and identify specific microbial pathways associated with probiotic supplementation in GI cancer patients.(04 years)
研究者
Mohammad Akram
Aligarh Muslim University