Commensal Oral Microbiota in Head and Neck Cancer (NCT03843554) | Clinical Trial Compass
TerminatedNot Applicable
Commensal Oral Microbiota in Head and Neck Cancer
Stopped: Study was terminated with 50% enrollment by the sponsor due to under enrollment into specific diverse racial, ethnic, and sex/gender categories.
https://grants.nih.gov/policy/inclusion/women-and-minorities.htm
United States60 participantsStarted 2019-09-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older;
✓. Able and willing to provide informed consent prior to initiation of study procedures;
✓. Scheduled to undergo radiation or chemoradiation treatment for head/neck cancer;
✓. Presents with at least one of nine areas of the oral or oropharyngeal mucosa (i.e., upper lip, lower lip, right cheek, left cheek, right ventral and lateral tongue, left ventral and lateral tongue, floor of the mouth, and soft palate) expected to receive at least 5000 cGy of RT. Patients with cancer located outside of the oral cavity will be included when at least 5000 cGy of RT will be administered to the oral cavity in addition to the RT targeted at the primary cancer site.
✓. Presents with a minimum of 6 natural teeth.
Exclusion criteria
✕. Pregnant or lactating at the baseline/screening visit;
✕. Participating in another oral health interventional research study at any point during their participation in this trial;
✕. Receiving induction chemotherapy or concurrent radiation therapy with cetuximab;
What they're measuring
1
Oral Mucosal Severity (Grade 3 or 4)
Timeframe: 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).
✕. Reports current use of antifungal or antibiotic at the time of enrollment;
✕. Presents with immunocompromised status (defined as an absolute neutrophil count (ANC) of less than 1000);
✕. Presents with any of the following conditions, which based on American Dental and American College of Cardiology guidelines, require antibiotic prophylaxis prior to dental treatment:
✕. prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts;
✕. prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords;