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NCT Number: NCT07809984

Prevention of Oral Mucositis in Adults in With Hematologic Malignancy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Christ Medical Center, Oak Lawn, Illinois, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Oral Mucositis

    Time frame: Day 28

    Number of participants that develop oral mucositis.

Secondary outcomes

  1. Participants with Worsening Grade of Mucositis

    Time frame: Day 28

    Number of participants with worsening grade of mucositis.

  2. Participants with Improving Grade of Mucositis

    Time frame: Day 28

    Number of participants with improving grade of mucositis.

Other outcomes

  1. Oral Mucositis Weekly Questionnaire Score

    Time frame: Baseline and every 7 days for 28 days

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt

CONTACT

[email protected]

336.716.9619

Tara Albrecht, PhD, ACNP-BC, ACHPN, RN

CONTACT

[email protected]

336.716.9619

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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