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NOT YET RECRUITING
NCT07809984
NA

Prevention of Oral Mucositis in Adults in With Hematologic Malignancy

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: Impact of Aloe Vera Mouthwash on the Prevention and Severity of Oral Mucositis in Adults in With Hematologic Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2026-10

Completion Date

2029-02

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Aloe Vera Mouthwash

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.

OTHER

Standard of Care

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.

Locations (3)

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