Clinical trial NCT01707641: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mucositis
Lead sponsor: S. Andrea Hospital
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: incidence of grade III/IV mucositis
timeFrame: 2 months
Secondary outcomes:
measure: percentage of patients able to complete the chemo-radiotherapy treatment
timeFrame: 2 months
Other outcomes:
measure: percentage of patients who need enteral nutrition
timeFrame: 2 months from enrolment
Locations:
city: Rome
country: Italy
facility: Sant'Andrea Hospital
Study officials:
affiliation: Sant'Andrea Hospital - Radiotherapy Unit
name: Vitaliana De Sanctis, PhD
role: PRINCIPAL_INVESTIGATOR
References: