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

NCT ID: NCT01707641

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2019-12-31

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.

Conditions

Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CD#2

patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2

Group Type: ACTIVE_COMPARATOR

CD#2

Intervention Type: DIETARY_SUPPLEMENT

patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth

bicarbonate sodium mouthwash

patients will be asked to wash their mouth with bicarbonate several times per day

Group Type: ACTIVE_COMPARATOR

bicarbonate sodium mouthwash

Intervention Type: OTHER

Patients will be asked to wash their mouth with bicarbonate sodium several times per day

Interventions

CD#2

patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth

Intervention Type: DIETARY_SUPPLEMENT

bicarbonate sodium mouthwash

Patients will be asked to wash their mouth with bicarbonate sodium several times per day

Intervention Type: OTHER

Other Intervention Names

Lozenge containing Lactobacillus brevis CD2

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S. Andrea Hospital

OTHER

Sponsor Role: lead

Responsible Party

Vitaliana De Sanctis

M.D. University Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vitaliana De Sanctis, PhD

Role: PRINCIPAL_INVESTIGATOR

Sant'Andrea Hospital - Radiotherapy Unit

Locations

Sant'Andrea Hospital

Rome, Rome, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vitaliana De Sanctis, PhD

Role: CONTACT

vitaliana.desanctis@uniroma1.it

Facility Contacts

Vitaliana De Sanctis, PhD

Role: primary

vitaliana.desanctis@uniroma1.it

Other Identifiers

CD2 AIRO

Identifier Type: -

Identifier Source: org_study_id