Phase 2
N=50
Herbal Mouthrinse for Oral Mucositis Study
Oral Mucositis
Bottom Line
View on ClinicalTrials.gov: NCT01898091 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Mar 2017
Primary outcome: Primary: 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*. — 1.91; 1.47 units on a scale — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neem Mouthrinse (Drug); Placebo Mouthrinse (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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*. |
1.91; 1.47 | 0.84 |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01898091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.