Herbal Mouthrinse for Oral Mucositis Study

Oral Mucositis Clinical Trial

— OM  

Official title:

Randomized Controlled Double-blinded Clinical Trial of an Herbal Mouthrinse for Radiotherapy Induced Mucositis in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898091
• Other study ID #: 101529
• Secondary ID: 1R21CA158530-01A
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2013
• Last updated: September 21, 2015
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• Neem Mouthrinse
10ml dose of 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum change in 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 which, once each week during the weeks of radiation therapy (an expected average of 7 weeks) and at the exit visit which coincides with the one month visit following completion of radiation therapy.	No
Secondary	Differences in quality of life between the two study groups measured by quality of life questionnaire.		Quality of life scores are collected at the baseline visit, once each week during the weeks of radiation therapy (an expected average of 7 weeks) and at the exit visit which coincides with the one month visit following completion of radiation therapy.	No