Herbal Mouthrinse for Oral Mucositis Study

NCT01898091 | Completed Phase 2 Results DMC

• 2 other identifiers: 1015291R21CA158530-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Oral; Mucositis; Stomatitis; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.

Study Arms (2)

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.

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.

Drug: Placebo Mouthrinse

Interventions

Neem Mouthrinse DRUG

10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.

Also known as: aloe, anise, ascorbic acid, clove, glycerin, extract of neem leaf, peppermint, poloxamer 407, potassium sorbate, spearmint, thyme, water, xylitol

Neem Mouthrinse

Placebo Mouthrinse DRUG

10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.

Also known as: aloe, anise, ascorbic acid, clove, glycerin, peppermint, poloxamer 407, potassium sorbate, spearmint, thyme, water, xylitol

Neem Mouthrinse; Placebo Mouthrinse

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425-9170, United States

Location

Related Publications (1)

• 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.

  PMID: 18973181 RESULT

MeSH Terms

Conditions

Stomatitis; Mucositis

Interventions

anise oil; Ascorbic Acid; Phosphatidylinositol 3-Kinases; Glycerol; peppermint oil; Poloxamer; Sorbic Acid; Water; Xylitol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Polyethylene Glycols; Ethylene Glycols; Glycols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Susan G. Reed, DDS, MPH, DrPH
• Organization: Medical University of South Carolina

reedsg@musc.edu

843 792-1577

Study Officials

• Susan G. Reed, DDS, DrPH

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 12, 2013
• Study Start: July 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 6, 2017
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)