Clinical trial · Interventional
Herbal Mouthrinse for Oral Mucositis Study
Randomized Controlled Double-blinded Clinical Trial of an Herbal Mouthrinse for Radiotherapy Induced Mucositis in Cancer Patients
NCT01898091CI-TRIAL-00026281OMcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study involves adults receiving radiation therapy for head and neck cancer and will test whether or not the study mouthrinse may lessen oral mucositis.
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 |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neem Mouthrinse | Drug | — | UNRESOLVED |
| Placebo Mouthrinse | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neem Mouthrinse
- description
- Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
- interventionNames
- Drug: Neem Mouthrinse
- Drug: Placebo Mouthrinse
- type
- PLACEBO_COMPARATOR
- label
- Placebo Mouthrinse
- description
- Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
- interventionNames
- Drug: Placebo Mouthrinse
Primary outcomes (1)
- measure
- Maximum Change in Mean Mouth and Throat Soreness (MTS) Score From Baseline Through Weeks of Radiation Therapy Using the MTS Question of the Modified Oral Mucositis Daily Questionnaire*.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: * Anatomic site: lip (inner aspect), oral cavity, pharynx or larynx; includes tonsils and salivary glands (ICD-9: 140-149 or 161). * Malignant tumor: ICD-O morphology 2 (in situ) or 3 (malignant, invasive or infiltrating). * Adult aged 18-89 years. * Patient recommended or planned to undergo radiotherapy to the head and neck regions, as part of their cancer treatment regimen. * Radiotherapy to be given in standard doses over a 4 - 7 week period. Exclusion Criteria: * Prior radiation treatment for cancer of the oral cavity, head or neck. * Baseline mouth and throat soreness (MTS) extreme score of 4. * Eastern Cooperative Oncology Group (ECOG) performance status \>2. * Unable to sign Informed Consent. * Known history of allergy to any of the mouthrinse constituents (aloe, anise, ascorbic acid, clove, glycerin, peppermint, poloxamer 407, potassium sorbate, spearmint, thyme, water, xylitol). * Inability to use a mouth rinse. * Patient unable to communicate with study personnel in English (either themselves or an interpreter).
References
Publications (1)
- RESULTElting LS, Keefe DM, Sonis ST, Garden AS, Spijkervet FK, Barasch A, Tishler RB, Canty TP, Kudrimoti MK, Vera-Llonch M; Burden of Illness Head and Neck Writing Committee. Patient-reported measurements of oral mucositis in head and neck cancer patients treated with radiotherapy with or without chemotherapy: demonstration of increased frequency, severity, resistance to palliation, and impact on quality of life. Cancer. 2008 Nov 15;113(10):2704-13. doi: 10.1002/cncr.23898. PMID 18973181