Clinical trial · Interventional
CD2 Lozenges in Preventing Acute Oral Mucositis in Patients With Head and Neck Cancer Receiving Radiotherapy and Chemotherapy
A Phase III, Randomized, Double-Blind Study of Lactobacillus Brevis CD2 Lozenges Versus Placebo in the Prevention of Acute Oral Mucositis (OM) in Patients With Head and Neck Cancer Receiving Concurrent Radiotherapy and Chemotherapy
- 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)
RATIONALE: Lactobacillus bevis CD2 lozenge may help prevent symptoms of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy. This therapy may improve the quality of life of patients with head and neck cancer. PURPOSE: This phase III trial studies how well Lactobacillus bevis CD2 lozenge prevents oral mucositis in patients with head and neck cancer who are being treated with cisplatin and radiation therapy. These results will be compared to results in patients using placebo lozenges.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Complications of Radiation Therapy | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus brevis CD2 lozenge | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients dissolve in mouth 1 lozenge of Lactobacillus bevis CD2 every 2-3 hours (total of 6 per day) daily during CRT (comprising cisplatin and radiotherapy \[RT\]) and for 4 weeks after, including weekends.
- interventionNames
- Dietary Supplement: Lactobacillus brevis CD2 lozenge
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients dissolve in mouth 1 lozenge of placebo every 2-3 hours (total of 6 per day) daily during CRT and for 4 weeks after, including weekends.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- The AUC of the MTS score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx * Planned course of definitive or post-operative radiotherapy (RT) to a total dose of ≥ 60 Gy using 1.8 to 2.0 Gy per fraction * At least one third of the oral cavity mucosa must be included in the RT fields, as estimated by the treating radiation oncologist * Planned concurrent administration of cisplatin chemotherapy (either 100 mg/m\^2 every 3 weeks or 30-40 mg/m\^2 every week) PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0, 1, or 2 * Hemoglobin ≥ 10.0 g/dL * White blood cell (WBC) ≥ 3,500 x10\^9/L * Absolute neutrophil count (ANC) ≥ 1,500 x10\^9/L * Platelet count ≥ 100,000 x10\^9/L * Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment * Ability to complete questionnaire(s) by themselves or with assistance * Willing to provide saliva samples for correlative research purposes (first 50 patients) * Not pregnant or nursing * Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential * Men or women of childbearing potential must employ adequate contraception * No co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * No current untreated oral candidiasis, oral herpes simplex virus (HSV) infection, or oral mucositis PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No split-course RT planned * No prior head and neck RT
References
Publications (0)
Data not yet available