Prevention of Oral Mucositis in Adults in With Hematologic Malignancy

Part of paid clinical trials in Oak Lawn, Illinois.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07809984
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Aloe Vera Mouthwash — DIETARY_SUPPLEMENT
    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.
  • Standard of Care — OTHER
    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.

Study Details

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.

Key Dates

First listed
Sep 9, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
206 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Phase 1 Usual Care
    Participants in the usual care phase will receive standard of care
  • Experimental: Phase 2 Intervention
    Participants in the intervention phase will receive aloe vera

Primary Outcome Measure

Incidence of Oral Mucositis [ Time Frame: Day 28 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Advocate Christ Medical CenterOak LawnIllinois60453
Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt
[email protected]
414.219.7744
Advocate Lutheran GeneralPark RidgeIllinois60068
Tara Albrecht, PhD
[email protected]
414-219-7744
Aurora St. Luke's Medical CenterMilwaukeeWisconsin53215-

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