Clinical trial NCT05369234: Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis
Official title: Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Cavity Cancer
Head and Neck Cancers - Tonsils
Esophageal Cancer
Laryngeal Cancer
Oropharynx Cancer
Mediastinal Cancer
Chest Wall Tumor
Radiation Mucositis
Lead sponsor: Thompson Cancer Survival Center
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort 1-Lip,oral cavity, hard palate, tongue, tonsil, pharyngeal, laryngeal, neck cancers receiving chemotherapy and radiation therapy will be randomized to receiving either aloe vera juice + standard of care treatments or standard of care treatments.

Cohort 2--Esophageal, mediastinal, chest wall cancers receiving chemotherapy and radiation will be randomized to receiving aloe vera juice + standard of care treatments or standard of care treatments.
Primary purpose: SUPPORTIVE_CARE

Brief summary: As mentioned above, several prior studies have shown the positive effects of oral use of aloe vera juice in managing chemotherapy and radiation-induced oral mucositis and esophagitis. This study aims to add to the existing body of research around aloe vera juice and its effects on oral mucositis and esophagitis. The intention is to determine whether aloe vera juice should be considered as part of standard treatment.

Detailed description: Oral mucositis and esophagitis are side effects of both chemotherapy and radiation that can interfere with a patient's ability to eat, drink, and maintain weight. They can significantly impact quality of life as well as creating the need for treatment breaks. Treatment breaks decrease the efficacy of treatment. A suspected method of treatment is aloe vera juice. Several prior studies have shown the positive effects of oral use of aloe vera juice in managing chemotherapy and radiation-induced oral mucositis and esophagitis. Aloe vera, or aloe barbadensis miller as it is known in the botanical world, is a succulent plant used in traditional medicine.

In this study, the aloe vera juice that will be utilized by the patients is George's 100% Aloe Vera Juice, manufactured by Warren Laboratories. This aloe vera juice has been fractionally distilled to remove anthraquinone and other compounds that can cause nausea, abdominal cramping, and diarrhea, as well as bitter, unpleasant taste.

This study aims to add to the existing body of research around aloe vera juice and its effects on oral mucositis and esophagitis. The intention is to determine whether aloe vera juice, in combination with standard treatments, is more effective in management of oral mucositis and esophagitis than standard treatment alone. If so, aloe vera offers a natural, cost-effective option for managing radiation and chemotherapy side effects.

Patients in arm 1 of cohort 1 or 2 will be given 3 gallons of George's 100% Aloe Vera Liquid Supplement, free of cost, to utilize throughout treatment. Patients in cohort 1, arm 2 will be asked to swish and spit ¼ cup (2 ounces) of the aloe vera juice 3 times per day, 7 days per week while they are on radiation treatment. Patients in cohort 2, arm 2 will be asked to drink ¼ cup (2 ounces) of aloe vera juice 3 times per day, 7 days per week while they are on chemotherapy and radiation treatment.

Eligibility criteria: Inclusion Criteria:

* must have signed and dated an IRB approved consent form that conforms to federal and institutional guidelines
* Age \>/= 18 years
* Confirmed lip, oral cavity, hard palate, tongue, tonsil, pharyngeal, neck, esophageal, mediastinal, and/or chest wall cancers
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* Men treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation.

Exclusion Criteria:

* Patients who are not on concurrent chemotherapy and radiation.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to aloe vera juice.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women or women who are breastfeeding

Primary outcomes:
measure: Prevention of Oral Mucositis and Esophagitis
timeFrame: 10 weeks
measure: Management of Oral Mucositis and Esophagitis
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center Radiation Oncology Services
state: Tennessee
Study officials:
affiliation: Thompson Cancer Survival Center
name: Daniel Scaperoth, MD
role: PRINCIPAL_INVESTIGATOR
References: