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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.

Phase 4
18 Years
Not Enrolling

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Trial Information

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.

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.

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 >

- 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

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

Type of Study:


Study Design:

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

Outcome Measure:

incidence of grade III/IV mucositis

Outcome Description:

Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Vitaliana De Sanctis, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sant'Andrea Hospital - Radiotherapy Unit


Ethics Committee, Italy ':'

Study ID:




Start Date:

November 2012

Completion Date:

December 2019

Related Keywords:

  • Mucositis
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis