| CTRI Number |
CTRI/2024/03/064552 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using probiotics to reduce the side effects and toxicities caused by chemoradiation treatment in patients of esophageal, colon, rectal and anal canal cancer. |
|
Scientific Title of Study
|
Characterization of gut dysbiosis in Gastrointestinal Malignancies and exploration of probiotics supplementation on therapeutic outcome in patients receiving chemoradiation in these malignancies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Akram |
| Designation |
Professor and Chairman |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Radiotherapy, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
201002
India |
| Phone |
8791385633 |
| Fax |
|
| Email |
akramhayat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Akram |
| Designation |
Professor and Chairman |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Radiotherapy, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
201002
India |
| Phone |
8791385633 |
| Fax |
|
| Email |
akramhayat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Akram |
| Designation |
Professor and Chairman |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Radiotherapy, J.N. Medical College and Hospital, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
201002
India |
| Phone |
8791385633 |
| Fax |
|
| Email |
akramhayat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New
Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New
Delhi - 110029, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Mohammad Akram |
Jawaharlal Nehru Medical College and Hospital |
OPD No. 19, Department of Radiotherapy, Faculty of Medicine,
Jawaharlal Nehru Medical College and
Hospital,
Aligarh Muslim University,
Aligarh.
Aligarh
UTTAR PRADESH |
8791385633
akramhayat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C211||Malignant neoplasm of anal canal, (2) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (3) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (4) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One capsule twice a day, along with radiation treatment, daily,
without break, for 7 weeks. |
| Intervention |
Probiotics |
Probiotics supplementation will have a combination of Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus brevis CD2 and Saccharomyces boulardii. One capsule twice a day, along with radiation treatment, daily, without break, for 7 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Biopsy proven cases of inoperable cases of carcinoma esophagus in which definitive chemoradiation is planned.
2. Biopsy proven cases of carcinoma colon.
3. Patient who have completed radical surgery in the form of hemi colectomy.
4. Patient in whom adjuvant chemotherapy is planned.
5. Biopsy proven cases of carcinoma rectum in which neoadjuvant chemoradiation is planned before definitive surgery.
6. Biopsy proven cases of carcinoma anal canal in which definitive chemoradiation is planned.
7. Karnofsky Performance Status KPS greater than 60 percent. |
|
| ExclusionCriteria |
| Details |
1. Patients who refuse to give their consent.
2. Serious co morbid diseases.
3. Post op patients.
4. History of any prior cancer, or coexisting tumours.
5. Patients with Immunity diseases Autoimmunity or Immunodeficiency.
6. Prior GI toxicities
7. Prior history of radiotherapy administration.
8. Prior probiotics or oral antibiotics intake within 15 days.
9. Metastatic disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The probiotics administration will ameliorate CRT induced toxicities in GI cancer patients thereby improving the response rates and prolonged progression free survival. |
04 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |