Prevention of Oral Mucositis in Adults in With Hematologic Malignancy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

206 Participants
are divided into 2 treatment groups
Group A: Phase 1 Usual CareActive comparator 1 intervention
Group B: Phase 2 InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Oral Mucositis

Number of participants that develop oral mucositis.

Time frame
Day 28

Secondary outcomes

1

Participants with Worsening Grade of Mucositis

Number of participants with worsening grade of mucositis.

Time frame
Day 28
2

Participants with Improving Grade of Mucositis

Number of participants with improving grade of mucositis.

Time frame
Day 28

Other outcomes

1

Oral Mucositis Weekly Questionnaire Score

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)

Time frame
Baseline and every 7 days for 28 days

Sponsors and contacts

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