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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by S. Andrea Hospital
Sponsor:
Information provided by (Responsible Party):
Vitaliana De Sanctis, S. Andrea Hospital
ClinicalTrials.gov Identifier:
NCT01707641
First received: October 12, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Mucositis
Dietary Supplement: CD#2
Other: bicarbonate sodium mouthwash
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by S. Andrea Hospital:

Primary Outcome Measures:
  • incidence of grade III/IV mucositis [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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:
  • percentage of patients able to complete the chemo-radiotherapy treatment [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • percentage of patients who need enteral nutrition [ Time Frame: 2 months from enrolment ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: November 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707641

Contacts
Contact: Vitaliana De Sanctis, PhD vitaliana.desanctis@uniroma1.it

Locations
Italy
Sant'Andrea Hospital Recruiting
Rome, Italy, 00189
Contact: Vitaliana De Sanctis, PhD       vitaliana.desanctis@uniroma1.it   
Principal Investigator: Vitaliana De Sanctis, PhD         
Sponsors and Collaborators
S. Andrea Hospital
Investigators
Principal Investigator: Vitaliana De Sanctis, PhD Sant'Andrea Hospital - Radiotherapy Unit
  More Information

No publications provided

Responsible Party: Vitaliana De Sanctis, M.D. University Researcher, S. Andrea Hospital
ClinicalTrials.gov Identifier: NCT01707641     History of Changes
Other Study ID Numbers: CD2 AIRO
Study First Received: October 12, 2012
Last Updated: May 19, 2014
Health Authority: Ethics Committee: Italy

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

ClinicalTrials.gov processed this record on September 30, 2014