Prevention of Oral Mucositis in Adults in With Hematologic Malignancy

ClinicalTrials.gov ID

NCT07809984

Lead Sponsor

Wake Forest University Health SciencesOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

206Estimated

Last Update Posted

Sep 9, 2026Actual

Start Date

Oct 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Feb 2029Estimated

Official Title

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

Brief 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.

Detailed Description

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).

• Acute Leukemia
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Oral Mucositis

• Aloe Vera Mouthwash
• Standard of Care

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Pregnant women
• Patients with an active eating disorder
• Patients receiving end of life/hospice care

Primary Purpose

Supportive Care

Allocation

Non-Randomized

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Wake Forest University Health SciencesOTHER

tara.albrecht@aah.org414-219-7744

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