Commensal Oral Microbiota in Head and Neck Cancer

Not Applicable

Terminated

• Conditions: Oral Mucositis; Head and Neck Cancer
• Interventions: Procedure: Oral mucosal deterging and dental prophylaxis; Other: Standard of Care Oral Hygiene

• Registration Number: NCT03843554
• Lead Sponsor: University of Pennsylvania

Brief Summary

The ARMOR Trial will test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. Participants will attend a screening/baseline visit, weekly intervention visits while they are undergoing RT or chemoRT, and a visit 3 months after completing RT or chemoRT. At intervention visits, samples will be collected (such as saliva, oral swabs) and participants will receive their assigned study intervention, either Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP), which includes a dental cleaning and treatment to the oral mucosa, or a Standard of Care Oral Hygiene, which includes teeth brushing and no treatment to the oral mucosa.

Detailed Description

This is a prospective, single blind, two arm, randomized, controlled trial to test the efficacy of an oral care protocol to treat oral mucositis (OM) in patients receiving radiation (RT) or chemoradiation (chemoRT) for head and neck cancer. This trial will also measure salivary proinflammatory cytokines, and evaluate other clinical effects of the intervention during cancer therapy. In addition, oral mucosal swabs will be collected for the future characterization of changes in the microbiome associated with OM severity.

Patients will be randomized in a 1:1 ratio to two different oral care protocols within 4 strata defined by type of RT (Proton beam therapy (Protons)) vs intensity-modulated radiation therapy (IMRT) and cancer treatment (RT versus chemoRT). Eligible subjects will be assigned to receive either the Oral Mucosal Deterging and Dental Prophylaxis protocol (OMDP) or a Standard of Care Oral Hygiene protocol (SOC-OH). Prior to randomization, all enrolled subjects will receive a baseline dental prophylaxis and fluoride varnish application prior to start of RT or chemoRT to ensure that all subjects enter the study with comparable oral health. Subjects assigned to OMDP will receive the OMDP Protocol (Oral Mucosal Deterging and Dental Prophylaxis) at weekly intervention visits. Subjects randomized to the SOC-OH will receive oral health instructions following the American Dental Association Guidelines and will have their teeth cleaned (brushed) during weekly intervention visits; no treatment to the oral mucosa will be provided to this group.

At each bi-weekly study visit, study assessments will include the collection of saliva and oral mucosal swabs, an oral exam and OM assessment, and the completion of questionnaires. During the course of the study, subjects will attend one baseline visit, up to 9 intervention visits, and a follow-up visit approximately 3 months after completion of RT. Local supportive care, including normal saline rinses, topical anesthetics, mixed medication mouthwashes (e.g. Magic Mouthwash), feeding tubes, and pain management will be allowed according to each recruitment site's standard of care procedures.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Study Start: 2019-09-23
• Primary Completion: 2022-08-03
• Study Completion: 2022-08-03
• Disposition First Submitted: 2023-05-02
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-23
• Disposition First Posted: 2023-06-27
• Last Update Posted: 2023-06-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Mucosal Deterging and Dental Prophylaxis (OMDP)	Oral mucosal deterging and dental prophylaxis	Oral Mucosal Deterging \& Dental Prophylaxis (OMDP) protocol: Subjects assigned to OMDP will attend weekly intervention visits during which they will have their teeth cleaned and will receive the OMDP intervention as follows: subjects will receive a professional dental prophylaxis including periodontal surface debridement and deterging of the oral mucosal surfaces. Subjects will be asked to follow OMDP oral hygiene instructions at home.
Standard of Care Oral Hygiene	Standard of Care Oral Hygiene	Standard of Care Oral Hygiene group (SOC-OH): Subjects assigned to SOC-OH will attend weekly oral care visits where they will have their teeth brushed with a soft bristled toothbrush by the interventionist. No treatment to the oral mucosa will be provided to this group as part of the intervention. Subjects will receive oral care instructions and will be asked to follow SOC oral hygiene instructions at home.

Primary Outcome Measures

Name	Time	Method
Oral mucosal severity	Baseline through 3 months post radiation therapy	Oral mucositis severity as measured by the World Health Organization's Oral Toxicity Scale (WHO OTS); severity is graded 0 through 4, with 4 being the worst. Grade 0 (none), Grade 1 (oral soreness, erythema), Grade 2 (ulceration, solid diet tolerated), Grade 3 (ulceration, liquid diet only), and Grade 4 (nothing by mouth).

Secondary Outcome Measures

Name	Time	Method
Correlative measures	Baseline through 3 months post radiation therapy	Salivary cytokines: Levels of Th1/Th2-type cytokines IL10, IL8, IL12p70, TNF alpha, IL4, IL1b, IL2, IL13, IL5, and IFN gamma will be assessed, in addition to levels of gp340.
Oral mucositis assessment	Baseline through 3 months post radiation therapy	Mucositis will be assessed using the WHO Oral Toxicity Scale (see above) and the NCI Common Terminology Criteria for Adverse Events (grade 1 through 5 with grade 5 being most severe/death)
Duration and time to onset of severe OM	Baseline through 3 months post radiation therapy	OM severity will be measured by a blinded member of the study team using the WHO OTS (previously described) and the duration and time to onset of severe OM measured in days.
Salivary hypofunction	Baseline through 3 months post radiation therapy	Changes in saliva flow rate (mL/minute) will be assessed by a 5 minute stimulated saliva collection.
Average mouth and throat soreness	Baseline through 3 months post radiation therapy	Average mouth and throat soreness (MTS) will be assessed using the validated Oral Mucositis and Daily Questionnaire (Stiff et al.)
QOL and Function	Baseline through 3 months post radiation therapy	Quality of life and function will be assessed using the validated EORTC-QLQ-C30 for head and neck cancers. This questionnaire assesses general quality of life as well as issues specific to head and neck cancer patients (e.g. difficulty swallowing, pain, dry mouth).
Progression free survival	Time from randomization to date of progression or death from any cause, whichever comes first, assessed up to 5 years after completion of RT	Progression free survival
Overall survival	Time from randomization to date of death from any cause, assessed assessed up to 5 years after completion of RT	Overall survival

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States