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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Mucositis
• Intervention / Treatment: Dietary supplement: CD#2; Other: bicarbonate sodium mouthwash

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Vitaliana De Sanctis, PhD; Email: vitaliana.desanctis@uniroma1.it

Study Locations

• Italy
  • Rome, Italy, 00189
    • Recruiting
    • Sant'Andrea Hospital
    • Contact: Vitaliana De Sanctis, PhD; Email: vitaliana.desanctis@uniroma1.it
    • Principal Investigator: Vitaliana De Sanctis, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CD#2; patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2	Dietary supplement: CD#2; patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth; Other Names: Lozenge containing Lactobacillus brevis CD2
Active Comparator: bicarbonate sodium mouthwash; patients will be asked to wash their mouth with bicarbonate several times per day	Other: bicarbonate sodium mouthwash; Patients will be asked to wash their mouth with bicarbonate sodium several times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 months

Secondary Outcome Measures

Outcome Measure	Time Frame
percentage of patients able to complete the chemo-radiotherapy treatment	2 months

Other Outcome Measures

Outcome Measure	Time Frame
percentage of patients who need enteral nutrition	2 months from enrolment

Collaborators and Investigators

• Sponsor: S. Andrea Hospital
• Investigators: Principal Investigator: Vitaliana De Sanctis, PhD, Sant'Andrea Hospital - Radiotherapy Unit

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis
• Other Study ID Numbers: CD2 AIRO