Trial Outcomes & Findings for Herbal Mouthrinse for Oral Mucositis Study (NCT NCT01898091)
NCT ID: NCT01898091
Last Updated: 2017-03-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.
Results posted on
2017-03-06
Participant Flow
Participant milestones
| Measure |
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 \[mouthrinse base plus 1% solution by weight of neem supercritical extract\], three times per day, for approximately 7 weeks during radiation therapy.
|
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 \[mouthrinse base\], three times per day, for approximately 7 weeks during radiation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
| Measure |
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 \[mouthrinse base plus 1% solution by weight of neem supercritical extract\], three times per day, for approximately 7 weeks during radiation therapy.
|
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 \[mouthrinse base\], three times per day, for approximately 7 weeks during radiation therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
Baseline Characteristics
Herbal Mouthrinse for Oral Mucositis Study
Baseline characteristics by cohort
| Measure |
Neem Mouthrinse
n=23 Participants
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.
|
Placebo Mouthrinse
n=19 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
61 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
59 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Gender
Male
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Neem Mouthrinse
n=23 Participants
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.
|
Placebo Mouthrinse
n=19 Participants
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.
|
|---|---|---|
|
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
|
1.47 units on a scale
Standard Deviation 1.22
|
Adverse Events
Neem Mouthrinse
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Mouthrinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Neem Mouthrinse
n=25 participants at risk
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 \[mouthrinse base plus 1% solution by weight of neem supercritical extract\], three times per day, for approximately 7 weeks during radiation therapy.
|
Placebo Mouthrinse
n=25 participants at risk
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 \[mouthrinse base\], three times per day, for approximately 7 weeks during radiation therapy.
|
|---|---|---|
|
General disorders
Respiratory insufficiency
|
4.0%
1/25 • Number of events 1 • 12 weeks
All adverse events are reported. The population includes a total of 50 patients, which includes 8 patients who were not evaluable for major outcome results.
|
0.00%
0/25 • 12 weeks
All adverse events are reported. The population includes a total of 50 patients, which includes 8 patients who were not evaluable for major outcome results.
|
Other adverse events
| Measure |
Neem Mouthrinse
n=25 participants at risk
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 \[mouthrinse base plus 1% solution by weight of neem supercritical extract\], three times per day, for approximately 7 weeks during radiation therapy.
|
Placebo Mouthrinse
n=25 participants at risk
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 \[mouthrinse base\], three times per day, for approximately 7 weeks during radiation therapy.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Exanthema
|
0.00%
0/25 • 12 weeks
All adverse events are reported. The population includes a total of 50 patients, which includes 8 patients who were not evaluable for major outcome results.
|
4.0%
1/25 • Number of events 1 • 12 weeks
All adverse events are reported. The population includes a total of 50 patients, which includes 8 patients who were not evaluable for major outcome results.
|
Additional Information
Susan G. Reed, DDS, MPH, DrPH
Medical University of South Carolina
Phone: 843 792-1577
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place