| CTRI Number |
CTRI/2011/11/002140 [Registered on: 17/11/2011] Trial Registered Retrospectively |
| Last Modified On: |
21/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mucositis is one of the most common problem in patients who are undergoing stem cell transplant receiving high dose chemotherapy in patients undergoing hematopoietic stem cell transplantation.
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Scientific Title of Study
|
“A pilot study of efficacy of Lactobacillus CD2 lozenges in preventing high-dose chemotherapy induced oral mucositis in patients undergoing hematopoietic stem cell transplantationâ€
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| 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,Institute Rotary Cancer Hospital ,
All India Institute of Medical Sciences
Medical Oncology,Institute Rotary Cancer Hospital ,
All India Institute of Medical Sciences
New Delhi
DELHI
110029
India |
| Phone |
01126589490 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul sharma |
| Designation |
additional professor |
| Affiliation |
|
| Address |
room no 229 2nd floor,deptt of medical oncology,institute rotary cancer hospital ,
all india institute of medical sciences
New Delhi
DELHI
110029
India |
| Phone |
01126589490 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul sharma |
| Designation |
additional professor |
| Affiliation |
|
| Address |
room no 229 2nd floor,deptt of medical oncology,institute rotary cancer hospital ,
all india institute of medical sciences
New Delhi
DELHI
110029
India |
| Phone |
01126589490 |
| Fax |
01126589490 |
| Email |
atul1@hotmail.com |
|
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Source of Monetary or Material Support
|
|
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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
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Sharma |
room no :229 2nd floor,institute rotary cancer hospital,all india institute of medical sciences |
ansari nagar
New Delhi
DELHI |
01126589490
01126589490
atul1@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee AIIMS |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Prevention of mucositis in the group of patients undergoing hematopoetic stem cell transplant, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lactobacillus CD2 lozenges |
The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient |
| Comparator Agent |
not applicable |
not applicable |
|
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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.
|
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| 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
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Not Applicable |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| 1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation |
daily assessment of mucositis till resolution or till 24 days.
whichever is earlier. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
2. Determine the incidence of Grade I and II mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation (Criteria for assessment is given in Appendix 1).
3. Duration of and time period for healing of chemotherapy induced oral mucositis.
4. Determine incidence and severity of dysphagia
|
daily assessment of mucostits till resolution or day 24 of the treatment. |
|
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Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
25/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Sharma A et al., Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced
mucositis in patients with head and neck cancer: A randomized double-blind placebo-controlled
study, Published online Eur J Cancer (2011), doi:10.1016/j.ejca.2011.06.010.
http://dx.doi.org/10.1016/j.ejca.2011.06.010 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and bone marrow) transplant) have a very high chance of developing severe oral mucositis (between 95-100%).This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at time feel difficult to continue treatment. No definite treatment exisits for prevention or treatment of oral mucositis in this group of patient .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 a probiotic Lactobacillus CD2 in reducing incidence and severity of chemo-radiotherapy induce mucositis in Head and neck squamous cell cancer patients.(Published one line in European journal of Cancer :http://dx.doi.org/10.1016/j.ejca.2011.06.010) .No significant toxitcity has been reported with its use. Now we want to study the effecacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. Study drug will be provided by CD pharma india Pvt Ltd. The study will be carried out as per ICH GCP and declaration of Helsinki. |