Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
Primary Purpose
Mucositis
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
CD#2
bicarbonate sodium mouthwash
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis
Eligibility Criteria
Inclusion Criteria:
- male and female patients > 18 years of age
- Karnofsky Performance Status >70%
- pathological and histological diagnosis that confirms head and neck tumour
- patients eligible for radical radiotherapy and/or chemotherapy
- expected survival time > 6 months
- normal bone marrow function (neutrophil count >1500/cmm, platelet count > 100.000/CMM)
- serum creatine < 1.8mg/dl
- total bilirubin <2mg/dl
- GOT, GPT within 3 times the normal limit
- willingness to perform conventional 3D radiotherapy or intensive modulated radiation therapy with concurrent chemotherapy
- signed informed consent form
Exclusion Criteria:
- Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
- Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
- Major surgery of the oral cavity within the last 4 weeks
- Patients previoucly treated with radiotherapy of head and neck
- Antifungal or antiviral therapy for oral pathological conditions in the last
- Other serious concomitant disease
- History of insulin-dependent Diabetes Mellituss
- History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis or Xerostomia
- Patients with body weigh >35 kg
- Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant
- Patients with Hepatitis B / C
- Patients with symptomatic untreated dental infection
- Patients with oral mucositis grade NCICTC 3 or 4
- Histological and pathological diagnosis unavailable
- Patients with signs and symptoms of systemic infection
- Patient's refusal to sign the informed consent
Sites / Locations
- Sant'Andrea HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CD#2
bicarbonate sodium mouthwash
Arm Description
patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
patients will be asked to wash their mouth with bicarbonate several times per day
Outcomes
Primary Outcome Measures
incidence of grade III/IV mucositis
Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
Secondary Outcome Measures
percentage of patients able to complete the chemo-radiotherapy treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01707641
Brief Title
Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
Official Title
A Randomized Study on the Effects of Lactobacillus Brevis CD2 in the Prevention of Radio and Chemotherapy Induced Oral Mucositis in Head and Neck Cancer Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
S. Andrea Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oral mucositis is a debilitating side effect for oncology patients and there is a clear need for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a potential new alternative for the prevention of grade III and IV mucositis. The main endpoint of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of grade III and IV mucositis as well as increase the percentage of patients who will complete the radio-chemotherapy treatment.
Detailed Description
Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology patients. It is not only painful, but also can limit adequate nutritional intake and decrease the willingness of patients to continue the treatment. Furthermore, extensive mucositis may require additional nutritional supplementation, and narcotic analgesic increasing the cost of the therapy. Quality of life is impaired in patients who develop severe mucositis.
Clinically, it begins with asymptomatic redness and erythema and ultimately passing through different stages to large acutely painful contiguous pseudomembranous lesions with associated dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal, soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the epithelial cells exposes the underlying connective tissue with its associated innervations causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further exacerbate the mucositis as well as lead to systemic infections.
Treatment and prevention of therapy related mucositis is essential; unfortunately, the efficacy and safety of most of the regimen used have not been clearly established. Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as mouthwash. Oral or parenteral narcotics are also used for pain relief.
There is a clear need for new therapeutic options for oral mucositis.
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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD#2
Arm Type
Active Comparator
Arm Description
patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
Arm Title
bicarbonate sodium mouthwash
Arm Type
Active Comparator
Arm Description
patients will be asked to wash their mouth with bicarbonate several times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
CD#2
Other Intervention Name(s)
Lozenge containing Lactobacillus brevis CD2
Intervention Description
patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth
Intervention Type
Other
Intervention Name(s)
bicarbonate sodium mouthwash
Intervention Description
Patients will be asked to wash their mouth with bicarbonate sodium several times per day
Primary Outcome Measure Information:
Title
incidence of grade III/IV mucositis
Description
Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
percentage of patients able to complete the chemo-radiotherapy treatment
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
percentage of patients who need enteral nutrition
Time Frame
2 months from enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male and female patients > 18 years of age
Karnofsky Performance Status >70%
pathological and histological diagnosis that confirms head and neck tumour
patients eligible for radical radiotherapy and/or chemotherapy
expected survival time > 6 months
normal bone marrow function (neutrophil count >1500/cmm, platelet count > 100.000/CMM)
serum creatine < 1.8mg/dl
total bilirubin <2mg/dl
GOT, GPT within 3 times the normal limit
willingness to perform conventional 3D radiotherapy or intensive modulated radiation therapy with concurrent chemotherapy
signed informed consent form
Exclusion Criteria:
Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
Major surgery of the oral cavity within the last 4 weeks
Patients previoucly treated with radiotherapy of head and neck
Antifungal or antiviral therapy for oral pathological conditions in the last
Other serious concomitant disease
History of insulin-dependent Diabetes Mellituss
History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis or Xerostomia
Patients with body weigh >35 kg
Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant
Patients with Hepatitis B / C
Patients with symptomatic untreated dental infection
Patients with oral mucositis grade NCICTC 3 or 4
Histological and pathological diagnosis unavailable
Patients with signs and symptoms of systemic infection
Patient's refusal to sign the informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vitaliana De Sanctis, PhD
Email
vitaliana.desanctis@uniroma1.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitaliana De Sanctis, PhD
Organizational Affiliation
Sant'Andrea Hospital - Radiotherapy Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sant'Andrea Hospital
City
Rome
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitaliana De Sanctis, PhD
Email
vitaliana.desanctis@uniroma1.it
First Name & Middle Initial & Last Name & Degree
Vitaliana De Sanctis, PhD
12. IPD Sharing Statement
Learn more about this trial
Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
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