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

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.

Condition or disease Intervention/treatment Phase
Mucositis Dietary Supplement: CD#2 Other: bicarbonate sodium mouthwash Phase 4

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  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : November 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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 Name: 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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. percentage of patients able to complete the chemo-radiotherapy treatment [ Time Frame: 2 months ]

Other Outcome Measures:
  1. percentage of patients who need enteral nutrition [ Time Frame: 2 months from enrolment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01707641

Contact: Vitaliana De Sanctis, PhD

Sant'Andrea Hospital Recruiting
Rome, Italy, 00189
Contact: Vitaliana De Sanctis, PhD   
Principal Investigator: Vitaliana De Sanctis, PhD         
Sponsors and Collaborators
S. Andrea Hospital
Principal Investigator: Vitaliana De Sanctis, PhD Sant'Andrea Hospital - Radiotherapy Unit

Responsible Party: Vitaliana De Sanctis, M.D. University Researcher, S. Andrea Hospital Identifier: NCT01707641     History of Changes
Other Study ID Numbers: CD2 AIRO
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases