Oral Mucositis
Conditions
Keywords
Oral, Mucositis, Stomatitis, Radiotherapy
Brief 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.
Detailed description
The broad goal of our research is development of an effective Complementary and Alternative Medicine (CAM) approach to prevent mucositis or lessen its severity and complications. Oral mucositis (OM) is a clinically challenging and debilitating side effect of conventional radiotherapy (RT), affecting almost all patients undergoing RT for head and neck cancer. OM includes inflammation of the oral mucosa with or without opportunistic microbial infection. It ranges from mild erythema to severe ulceration accompanied by persistent pain leading to inability to tolerate or swallow food and fluids. OM frequently causes unwanted cancer treatment dose reductions or breaks in therapy. Despite use of pain medications, severe OM is associated with substantially increased use of costly health care resources. Presently, there are no effective treatments for OM. The primary aim of the current proposal is to determine whether or not a mouthrinse containing an herbal extract with known anti-inflammatory and anti-microbial medicinal properties, will reduce the severity of oral mucositis in cancer patients undergoing conventional radiotherapy to the head and neck. Because of the prominent inflammatory and microbial aspects of OM we anticipate that the herbal mouthrinse will reduce the severity of the pain and secondary infections associated with OM, and will improve the quality of life in head and neck cancer patients undergoing RT. Therefore, the specific aims of our Phase II double-blind, randomized, controlled trial are 1) to determine if the severity of oral mucositis is reduced in RT patients receiving the herbal mouthrinse compared to patients receiving the comparison mouthrinse and 2) to determine the effects of the herbal mouthrinse on the microbial environment of the oral cavity and on quality of life. Findings from this study will provide evidence to support more in-depth biological assessment of the anti-inflammatory and anti-microbial mechanisms by which the herbal extract reduces oral mucositis, and additional study in other populations experiencing mucositis.
Interventions
DRUGNeem Mouthrinse
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Sponsors
National Cancer Institute (NCI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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*. | MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy. | Severity is assessed as the maximum change in mean mouth and throat soreness (MTS) score from baseline during the weeks of RT, using MTS question of the validated Oral Mucositis Daily Questionnaire (modified OMDQ): During the past 24 hours, how much mouth and throat soreness did you have? The MTS score is a 5-point score, ranging from 0=No soreness to 4=Extreme soreness. We compared the maximum change in MTS score between the two groups using the Wilcoxon rank sum test with a one-sided alpha of 0.05. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neem Mouthrinse 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.
Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy. | 23 |
| Placebo Mouthrinse 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.
Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy. | 19 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | Neem Mouthrinse | Placebo Mouthrinse | Total |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 13.4 | 61 years STANDARD_DEVIATION 11.5 | 59 years STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 19 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 7 Participants | 4 Participants | 11 Participants |
| Gender Male | 16 Participants | 15 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 17 Participants | 33 Participants |
| Region of Enrollment United States | 23 participants | 19 participants | 42 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 1 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 |
Outcome results
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*.
Severity is assessed as the maximum change in mean mouth and throat soreness (MTS) score from baseline during the weeks of RT, using MTS question of the validated Oral Mucositis Daily Questionnaire (modified OMDQ): During the past 24 hours, how much mouth and throat soreness did you have? The MTS score is a 5-point score, ranging from 0=No soreness to 4=Extreme soreness. We compared the maximum change in MTS score between the two groups using the Wilcoxon rank sum test with a one-sided alpha of 0.05.
Time frame: MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.
Population: Exclusion criterion was those with a baseline mouth and throat soreness (MTS) extreme score of 4.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neem Mouthrinse | 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 units on a scale | Standard Deviation 1.34 |
| Placebo Mouthrinse | 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*. | 1.47 units on a scale | Standard Deviation 1.22 |
Comparison: Simulations determined power to detect significant difference defined as a mean difference of 1 unit (MTS scale). Feasibility study provided proportion of patients in control and neem group with change scores of 0, 1, 2, 3, and 4 as (5%, 10%, 10%, 45% and 30%) and (15%, 20%, 30%, 25% and 10%), respectively. Simulated 10,000 trials using multinomial distributions by the percentages above, with 20 patients per group, provided 80% power to detect 0.9 unit difference using a one-sided alpha of 0.05.p-value: 0.84Wilcoxin rank sum test