About this trial
The goal of this quasiexperimental cohort controlled intervention study is to learn if aloe vera mouthwash works better than usual care in the prevention and treatment of oral mucositis. Researchers will compare aloe vera to usual care. Participants in the intervention group will rinse their mouths with aloe vera 4 x/day for 28 days of their treatment. They will also complete questionnaires about oral health and mucositis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Medical diagnosis of acute leukemia and receiving high or low intensity chemotherapy
English speaking/reading (without an interpreter)
Access to a personal email address to support study participation
Disqualifiers
Patients with preexisting mucositis.
Allergy to Aloe Vera
Transplant patients
Cognitively impaired or have a psychiatric condition that would prevent ability to provide informed consent
Trial design
Single group
Treatments tested in this trial
Aloe Vera Mouthwash
Dietary supplementIn addition to standard of care, phase 2 participants will receive the aloe vera mouthwash available for order through supply chain services. Health system pharmacy has approved this as a nonmedication and safe for administration with this patient population and other medications. Each participant will have their own bottle and be instructed to swish and spit 15ml (0.5 ounces) of mouthwash following usual oral care prior to meals and at bedtime (four times per day). Nursing staff assess the participants' oral cavity at least twice a day for mucosal integrity, pain, bleeding, or ulceration. While participants are inpatient, the routine oral assessments and administration of the aloe vera will be tracked via documentation in the electronic health record. If participants are discharged prior to 28 days, oral assessments and aloe vera use will be tracked via self-report by participants on the weekly questionnaire.
Standard of Care
Other interventionToothbrushing with a soft or ultra-soft toothbrush and fluoride toothpaste a minimum of twice a day, oral rinsing with water or 0.9% sodium chloride four times daily, and denture care as applicable.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Oral Mucositis
Number of participants that develop oral mucositis.
Secondary outcomes
Participants with Worsening Grade of Mucositis
Number of participants with worsening grade of mucositis.
Participants with Improving Grade of Mucositis
Number of participants with improving grade of mucositis.
Other outcomes
Oral Mucositis Weekly Questionnaire Score
The Oral Mucositis Weekly Questionnaire is a patient-reported outcome instrument developed to measure oral mucositis impact on patients' daily life. The questionnaire includes 12 items that are individually assessed including: Global health and Quality of life with 2 items rated on 1-7 scale (higher score better); Mouth and throat soreness when present is measured with 7 items on 0-4 scale and 1 overall measure on 0-10 scale; mouth pain and throat pain are also each measured using 0-10 scale (lower scores better)
Sponsors and contacts
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