Lactobacillus Brevis CD2 Preventing Oral Mucositis
Primary Purpose
Mucositis
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus brevis CD2
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 65 years
- Karnofsky Performance Score ≥ 70%.
- Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
- Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
- Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
- Serum creatinine < 1.8mg/dl
- Total bilirubin < 2mg/dl
- Liver enzymes within three times of normal limit
- Expected survival > 6 months.
Exclusion Criteria:
- Pregnant women and lactating mothers
- Patients with history of HIV infection
- Patients who have taken any other investigational product in last 4 weeks
- Patients having untreated symptomatic dental infection
- Patients with WHO Grade 3 or 4 oral Mucositis
- Other serious concurrent illness
- Inconclusive hematological diagnosis
- Patients with signs and symptoms of systemic infections
- Patient's/guardian's refusal to sign informed consent
Sites / Locations
- Policlinico Universitario "A. GEMELLI"Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lactobacillus brevis CD2 lozenges
Arm Description
Outcomes
Primary Outcome Measures
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
Secondary Outcome Measures
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM
Full Information
NCT ID
NCT02085694
First Posted
March 6, 2014
Last Updated
March 8, 2014
Sponsor
Catholic University of the Sacred Heart
1. Study Identification
Unique Protocol Identification Number
NCT02085694
Brief Title
Lactobacillus Brevis CD2 Preventing Oral Mucositis
Official Title
A Pilot Study on the Efficacy of Lactobacillus Brevis CD2 Lozenges in Preventing Oral Mucositis by High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A pilot study on efficacy of Lactobacillus CD2 lozenges in preventing oral mucositis (OM) by high-dose chemotherapy with autologous hematopoietic stem cell transplantation. To test whether the probiotic Lactobacillus brevis CD2 lozenges can reduce the incidence and severity of high-dose chemotherapy conditioning regimen induced OM in patients undergoing HSCT.
Clinical activity will be defined as reduction in the incidence of chemotherapy induced OM in the patients undergoing HSCT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactobacillus brevis CD2 lozenges
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lactobacillus brevis CD2
Primary Outcome Measure Information:
Title
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
Time Frame
days -14;-7; 0;+7;+14;+21
Secondary Outcome Measure Information:
Title
COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM
Time Frame
days -14;-7; 0; +7;+14; +21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 65 years
Karnofsky Performance Score ≥ 70%.
Confirmed histological diagnosis of multiple myeloma for which HSCT is as approved modality of therapy
Patients eligible to receive high-dose chemotherapy as part of conditioning regimen
Concomitant co morbid condition if present, controlled by ongoing treatments (e.g. hypertension, diabetes and so on)
Serum creatinine < 1.8mg/dl
Total bilirubin < 2mg/dl
Liver enzymes within three times of normal limit
Expected survival > 6 months.
Exclusion Criteria:
Pregnant women and lactating mothers
Patients with history of HIV infection
Patients who have taken any other investigational product in last 4 weeks
Patients having untreated symptomatic dental infection
Patients with WHO Grade 3 or 4 oral Mucositis
Other serious concurrent illness
Inconclusive hematological diagnosis
Patients with signs and symptoms of systemic infections
Patient's/guardian's refusal to sign informed consent
Facility Information:
Facility Name
Policlinico Universitario "A. GEMELLI"
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Chiusolo, MD
Phone
0039-0630155300
Email
p.chiusolo@rm.unicatt.it
First Name & Middle Initial & Last Name & Degree
Sabrina Giammarco, MD
Phone
0039-0630155300
Email
sabrina_giammarco@libero.it
First Name & Middle Initial & Last Name & Degree
Patrizia Chiusolo, MD
First Name & Middle Initial & Last Name & Degree
Sabrina Giammarco, MD
12. IPD Sharing Statement
Learn more about this trial
Lactobacillus Brevis CD2 Preventing Oral Mucositis
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