Commensal Oral Microbiota in Head and Neck Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT03843554
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care Oral Hygiene — OTHER
    Standard of care oral hygiene- weekly oral care visits with soft-bristled toothbrushing.
  • Oral mucosal deterging and dental prophylaxis — PROCEDURE
    Subjects will receive a professional dental prophylaxis including periodontal surface debridement \[a light-touch, gentle form of instrumentation performed with an ultrasonic instrument to promote plaque removal, to facilitate biofilm disruption and endotoxin flushing, but yet with the preservation of the periodontal cementum\] and deterging of the oral mucosal surfaces.

Study Details

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.

Key Dates

Start date
Sep 23, 2019
Status verified
Sep 2025
Primary completion
Aug 3, 2022
Completion
Aug 3, 2022

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Mucosal Deterging and Dental Prophylaxis (OMDP)
    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.
  • Placebo Comparator: 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 Measure

Oral Mucosal Severity (Grade 3 or 4) [ Time Frame: Week 1 (Day 0/Randomization) - Week 8 (Day 56) during radiation therapy. Change from Baseline to Final Intervention Visit (FIV) is the endpoint being analyzed at this single timepoint (Day 56 relative to Day 0). ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Pennsylvania· Philadelphia, PA

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