| CTRI Number |
CTRI/2013/02/003393 [Registered on: 14/02/2013] Trial Registered Prospectively |
| Last Modified On: |
27/11/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy.Lactobacillus cd2(probiotics is being investigated)in this study in the prevention of mucositis(oral ulcers). |
|
Scientific Title of Study
|
A Randomized Double Blind Placebo Controlled Phase III Study of Efficacy of Lactobacillus CD2 lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul sharma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no:229 2nd floor,Deptt of Medical Oncology,Inst Rotary Cancer Hospital,All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
919818548149 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul sharma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no:229 2nd floor,Deptt of Medical Oncology,Inst Rotary Cancer Hospital,All India Institute of Medical Sciences
DELHI
110029
India |
| Phone |
919818548149 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul sharma |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room no:229 2nd floor,Deptt of Medical Oncology,Inst Rotary Cancer Hospital,All India Institute of Medical Sciences
DELHI
110029
India |
| Phone |
919818548149 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CD Pharma India Pvt Ltd |
| Address |
C-1/53 Ist floor Safdarjung development area,new delhi 110016.INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Sharma |
Dr BRA Institute Rotary Cancer Hospital,AIIMS |
Ansari Nagar
New Delhi
DELHI |
919818548149
01126589490
atul1@hotmail.com |
| Dr Dinesh Bhurani |
Rajiv Gandhi Cancer Institute and Research Center |
Sector V,Rohini
North West
DELHI |
9971500861
bhurani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee AIIMS |
Approved |
| Institutional Review Board RGCI |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prevention of mucositis in the group of patients undergoing myeloablative hematopoetic stem cell transplant , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactobacillus CD2 lozenges |
It contains not less than 2x109 viable cells of Lactobacillus CD2 as active ingredient. |
| Comparator Agent |
placebo |
Placebo contains a mix of fillers (like mannitol and fructose) and excipients but without the active drug. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 10 and 70 years.
2. Karnofsky Performance Score ≥ 70%.
3. Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is as approved modality of therapy.
4. Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
5. Concomitant co morbid condition if present, controlled by medicines.
6. Serum creatinine  1.8mg/dl.
7. Total bilirubin  2mg/dl.
8. Liver enzymes within three times of normal limit.
9. Expected survival > 6 months
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mothers.
2. Patients with history of AIDS
3. Patients who have taken any other investigational product in last 4 weeks.
4. Patients having untreated symptomatic dental infection.
5. Patients with WHO Grade 3 or 4 oral Mucositis.
6. Other serious concurrent illness.
7. Inconclusive histological diagnosis.
8. Patients on anticancer antibiotics.
9. Patients with signs and symptoms of systemic infections.
10. Patient’s/guardian’s refusal to sign informed consent.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
|
| Outcome |
TimePoints |
| Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups. |
daily assessment of mucostits till resolution or day 24 of the treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups .
2. Duration of and time period for healing of chemotherapy induced oral mucositis.
3. Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups
|
daily assessment of mucostits till resolution or day 24 of the treatment. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
29/03/2013 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
European Journal of Cancer 2012;
4:875-881
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and bone marrow) transpalnt have high chances of developing severe oral mucositis(between 95-100%).The mucositis not only causes significant morbidity but also hampers the quality of life so much that pateints at time feel difficult to continue treatment. No definite treatment exist for prevention and treatment of mucositis in this group of patients.Though one study has suggested that the use of IV palifermin ( a keratinocyte growth factor) will reduce duration and severity of mucositis.Palifermin is very expensive and not available in country.Recently we have shown effectiveness of probiotic Lactobacillus CD2 in reducing incendence and severity of chemo-radiotherapy induce mucositis in Head and Neck squamous cell cancer patients.(Published in European Journal of Cancer 2012;4:875-881) No significant toxicity has been reported with its use. Now we want to study the efficacy of this drug to reduce the severity of mucositis in patient undergoing myeloablative hematopoetic stem cell transplantation. Study drug will be provided by the CD Pharma India Pvt Ltd. The study will be carried out as per ICH GCP and decleration of Helsinki. |