Herbal Mouthrinse for Oral Mucositis Study (OM)

January 13, 2017 updated by: Susan G. Reed, Medical University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425-9170
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Neem Mouthrinse
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Other Names:
  • ascorbic acid
  • aloe
  • anise
  • clove
  • glycerin
  • extract of neem leaf
  • peppermint
  • poloxamer 407
  • potassium sorbate
  • spearmint
  • thyme
  • water
  • xylitol
Drug: Placebo Mouthrinse
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Other Names:
  • ascorbic acid
  • aloe
  • anise
  • clove
  • glycerin
  • peppermint
  • poloxamer 407
  • potassium sorbate
  • spearmint
  • thyme
  • water
  • xylitol
Placebo Comparator: 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.
Drug: Placebo Mouthrinse
10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
Other Names:
  • ascorbic acid
  • aloe
  • anise
  • clove
  • glycerin
  • peppermint
  • poloxamer 407
  • potassium sorbate
  • spearmint
  • thyme
  • water
  • xylitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Susan G. Reed, DDS, DrPH, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101529
  • 1R21CA158530-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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