Characterization of gut dysbiosis in Gastrointestinal Malignancies and exploration of probiotics supplementation on therapeutic outcome in patients receiving chemoradiation in these malignancies.
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival.
Time Frame: 04 years
Secondary Outcomes
- 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)
Investigators
Mohammad Akram
Aligarh Muslim University