Oral MucositisPhase 2OMNCT01898091
Herbal Mouthrinse for Oral Mucositis Study
A Phase 2 study testing Neem Mouthrinse in people with Oral Mucositis, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Neem Mouthrinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425-9170
About this study
Official title: Randomized Controlled Double-blinded Clinical Trial of an Herbal Mouthrinse for Radiotherapy Induced Mucositis in Cancer Patients
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.
Read the 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.
- Conditions
- Oral Mucositis
- Being tested
- Neem Mouthrinse, Placebo Mouthrinse
- Keywords
- Oral, Mucositis, Stomatitis, Radiotherapy
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neem MouthrinseDrug
Also called aloe, anise, ascorbic acid, clove
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Placebo MouthrinseDrug
Also called aloe, anise, ascorbic acid, clove
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Neem Mouthrinse | Experimental | 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. Receives: Drug: Neem Mouthrinse; Drug: Placebo Mouthrinse |
| Placebo Mouthrinse | Placebo comparator | 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. Receives: Drug: Placebo Mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Susan G. Reed, Medical University of South Carolina
- Investigators
- Susan G. Reed, DDS, DrPH, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898091
- Sponsor's protocol ID
- 101529
- Other IDs
- 1R21CA158530-01A1
- Acronym
- OM
- Status last verified
- Jan 2017
- First submitted
- 2 Jul 2013
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After publication of the results of the primary and secondary endpoints of the trial, we will offer our collected experience to other interested clinicians/scientists. Our first priority is that any data sets that are used be subject of a confidentiality agreement. Any clinical data that is shared will be stripped of any subject personal information (de-indentified data). Our intent, if the trial results are promising is to share the findings through the HCC Clinical Trial Network. If our intervention is useful we are open to further investigation though clinical trial and other cooperative groups. Dr. Susan Reed, as PI, will participate in all sharing activities.
Publications
Elting 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.
PubMed 18973181
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double-blinded Clinical Trial of an Herbal Mouthrinse for Radiotherapy Induced Mucositis in Cancer Patients
- ClinicalTrials.gov ID
- NCT01898091
- Acronym / sponsor ID
- OM / 101529
- Conditions
- Oral Mucositis
- Keywords
- Oral, Mucositis, Stomatitis, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neem Mouthrinse | Experimental | Drug: Neem Mouthrinse, Drug: Placebo MouthrinseParticipants 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 | Placebo comparator | Drug: Placebo MouthrinseParticipants 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neem MouthrinseAlso: aloe, anise, ascorbic acid, clove10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy. | Drug | Neem Mouthrinse |
| Placebo MouthrinseAlso: aloe, anise, ascorbic acid, clove10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy. | Drug | Neem Mouthrinse, Placebo Mouthrinse |
Primary outcome
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*.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18973181Elting 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.
- Individual participant dataSharing planned: Yes. After publication of the results of the primary and secondary endpoints of the trial, we will offer our collected experience to other interested clinicians/scientists. Our first priority is that any data sets that are used be subject of a confidentiality agreement. Any clinical data that is shared will be stripped of any subject personal information (de-indentified data). Our intent, if the trial results are promising is to share the findings through the HCC Clinical Trial Network. If our intervention is useful we are open to further investigation though clinical trial and other cooperative groups. Dr. Susan Reed, as PI, will participate in all sharing activities.
Related trials for Oral Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
RecruitingPhase 4
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Stomatitis
RecruitingPhase 3
A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.
Head & Neck Cancer, Oral Mucositis
Recruiting
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan G. Reed, DDS, DrPH principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neem Mouthrinse in people with Oral Mucositis, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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*. (time frame: MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01898091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.