Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bicarbonate sodium mouthwash | Other | — | UNRESOLVED |
| CD#2 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CD#2
- description
- patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
- interventionNames
- Dietary Supplement: CD#2
- type
- ACTIVE_COMPARATOR
- label
- bicarbonate sodium mouthwash
- description
- patients will be asked to wash their mouth with bicarbonate several times per day
- interventionNames
- Other: bicarbonate sodium mouthwash
Primary outcomes (1)
- measure
- incidence of grade III/IV mucositis
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available