NCT02085694UnknownPhase 2
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
Catholic University of the Sacred Heart1 site in 1 country10 target enrollmentStarted: March 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) for evaluation of change in oral mucositis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lactobacillus brevis CD2 lozenges
Experimental
Intervention: Lactobacillus brevis CD2 (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS v4.03 (CTCAE) to determine the incidence of Grade I and II OM(days -14;-7; 0; +7;+14; +21)
Investigators
sabrina giammarco
MD
Catholic University of the Sacred Heart
Study Sites (1)
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