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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01707641
Recruitment Status : Recruiting
First Posted : October 16, 2012
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):
Vitaliana De Sanctis, S. Andrea Hospital

October 12, 2012
October 16, 2012
May 20, 2014
November 2012
December 2014   (Final data collection date for primary outcome measure)
incidence of grade III/IV mucositis [ Time Frame: 2 months ]
Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
Same as current
Complete list of historical versions of study NCT01707641 on Archive Site
percentage of patients able to complete the chemo-radiotherapy treatment [ Time Frame: 2 months ]
Same as current
percentage of patients who need enteral nutrition [ Time Frame: 2 months from enrolment ]
Same as current
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Dietary Supplement: CD#2
    patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth
    Other Name: Lozenge containing Lactobacillus brevis CD2
  • Other: bicarbonate sodium mouthwash
    Patients will be asked to wash their mouth with bicarbonate sodium several times per day
  • Active Comparator: CD#2
    patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
    Intervention: Dietary Supplement: CD#2
  • Active Comparator: bicarbonate sodium mouthwash
    patients will be asked to wash their mouth with bicarbonate several times per day
    Intervention: Other: bicarbonate sodium mouthwash
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2019
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Vitaliana De Sanctis, PhD
Not Provided
Not Provided
Vitaliana De Sanctis, S. Andrea Hospital
S. Andrea Hospital
Not Provided
Principal Investigator: Vitaliana De Sanctis, PhD Sant'Andrea Hospital - Radiotherapy Unit
S. Andrea Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP