Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer

Phase 4

• Conditions: Mucositis
• Interventions: Dietary Supplement: CD#2; Other: bicarbonate sodium mouthwash

• Registration Number: NCT01707641
• Lead Sponsor: S. Andrea Hospital

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.

Study Timeline

• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2012-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20
• Primary Completion: 2014-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

1. Diagnosis of glottic tumour, parotid or salivary, larynx tumour.
2. Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC
3. Major surgery of the oral cavity within the last 4 weeks
4. Patients previoucly treated with radiotherapy of head and neck
5. Antifungal or antiviral therapy for oral pathological conditions in the last
6. Other serious concomitant disease
7. History of insulin-dependent Diabetes Mellituss
8. History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis or Xerostomia
9. Patients with body weigh >35 kg
10. Women of childbearing potential who are pregnant, breast-feeding or intend to become pregnant
11. Patients with Hepatitis B / C
12. Patients with symptomatic untreated dental infection
13. Patients with oral mucositis grade NCICTC 3 or 4
14. Histological and pathological diagnosis unavailable
15. Patients with signs and symptoms of systemic infection
16. Patient's refusal to sign the informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD#2	CD#2	patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
bicarbonate sodium mouthwash	bicarbonate sodium mouthwash	patients will be asked to wash their mouth with bicarbonate several times per day

Primary Outcome Measures

Name	Time	Method
incidence of grade III/IV mucositis	2 months	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

Name	Time	Method
percentage of patients able to complete the chemo-radiotherapy treatment	2 months

Trial Locations

Locations (1)

Sant'Andrea Hospital; 🇮🇹 Rome, Italy