Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Oral Mucositis
Conditions
Keywords
acute leukemia, supportive care, aloe vera, symptom management
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).
Interventions
DIETARY_SUPPLEMENTAloe 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.
OTHERStandard 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This study will apply a quasiexperimental cohort-controlled design. Phase 1 will enroll usual care group and Phase 2 will enroll intervention group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Oral Mucositis | Day 28 | Number of participants that develop oral mucositis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants with Worsening Grade of Mucositis | Day 28 | Number of participants with worsening grade of mucositis. |
| Participants with Improving Grade of Mucositis | Day 28 | Number of participants with improving grade of mucositis. |
Countries
United States
Contacts
CONTACTTara Albrecht, PhD, ACNP-BC, ACHPN, RN
CONTACTJeanne Hlebichuk, PhD, RN, NE-BC, LSS Black Belt
PRINCIPAL_INVESTIGATORTara Albrecht, PhD, ACNP-BC, ACHPN, RN
Advocate Health
Outcome results
None listed