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.
Oral mucositis (OM) is a common and debilitating complication of chemotherapy and radiotherapy among adults with acute leukemia, leading to pain, infection risk, treatment delays, and reduced quality of life. This multi-site, cohort controlled quasi-experimental study will evaluate the effectiveness of a nurse-led aloe vera mouthwash intervention compared with usual oral care in preventing and reducing the incidence and severity of OM among hospitalized oncology patients. Primary outcomes include OM incidence and severity measured by Common Terminology Criteria for Adverse Events (CTCAE), with secondary outcomes of pain, quality of life, and overall health assessed weekly using the Oral Mucositis Weekly Questionnaire (OMWQ).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
206
In 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.
Toothbrushing 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.
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Advocate Lutheran General
Park Ridge, Illinois, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Incidence of Oral Mucositis
Number of participants that develop oral mucositis.
Time frame: Day 28
Participants with Worsening Grade of Mucositis
Number of participants with worsening grade of mucositis.
Time frame: Day 28
Participants with Improving Grade of Mucositis
Number of participants with improving grade of mucositis.
Time frame: Day 28
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