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

Mucositis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01707641
• Other study ID #: CD2 AIRO
• Status: Recruiting
• Phase: Phase 4
• First received: October 12, 2012
• Last updated: May 19, 2014
• Start date: November 2012
• Est. completion date: December 2019

Study information

• Verified date: May 2014
• Source: S. Andrea Hospital
• Contact: Vitaliana De Sanctis, PhD
• Email: vitaliana.desanctis[@]uniroma1.it
• Is FDA regulated: No
• Health authority: Ethics Committee: Italy
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2019
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Stomatitis

Intervention

Dietary Supplement:
• CD#2
patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth

Other:
• bicarbonate sodium mouthwash
Patients will be asked to wash their mouth with bicarbonate sodium several times per day

Locations

Country	Name	City	State
Italy	Sant'Andrea Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
S. Andrea Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	percentage of patients who need enteral nutrition		2 months from enrolment	No
Primary	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	No
Secondary	percentage of patients able to complete the chemo-radiotherapy treatment		2 months	No