Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis

Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis: a Single-blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Laryngeal Cancer; Esophageal Cancer; Oropharynx Cancer; Oral Cavity Cancer; Mediastinal Cancer; Head and Neck Cancers - Tonsils; Chest Wall Tumor; Radiation Mucositis
• Intervention / Treatment: Dietary supplement: 100% Aloe Vera Juice; Combination product: Magic Mouthwash; Combination product: Salt and Baking soda rinse; Drug: Carafate

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Thompson Cancer Survival Center Radiation Oncology Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1--Arm 1; Aloe Vera Juice + Standard of Care Treatments Swish and spit ¼ cup (2 ounces) of 100% aloe vera juice 3 times per day, 7 days per week as first line treatment, standard of care agents added as needed	Dietary supplement: 100% Aloe Vera Juice; George's 100% Aloe Vera Liquid Supplement; Combination product: Magic Mouthwash; Magic Mouthwash; Combination product: Salt and Baking soda rinse; Mouth rinse made with salt and baking soda; Drug: Carafate; Carafate taken as a slurry
Active Comparator: Cohort 1--Arm 2; Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.	Combination product: Magic Mouthwash; Magic Mouthwash; Combination product: Salt and Baking soda rinse; Mouth rinse made with salt and baking soda; Drug: Carafate; Carafate taken as a slurry
Experimental: Cohort 2--Arm 1; Aloe Vera Juice + Standard of Care Treatments Drink ¼ cup (2 ounces) of 100% aloe vera juice 3 times per day, 7 days per week as first line treatment, standard of care agents added as needed	Dietary supplement: 100% Aloe Vera Juice; George's 100% Aloe Vera Liquid Supplement; Combination product: Magic Mouthwash; Magic Mouthwash; Combination product: Salt and Baking soda rinse; Mouth rinse made with salt and baking soda; Drug: Carafate; Carafate taken as a slurry
Active Comparator: Cohort 2-- Arm 2; Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.	Combination product: Magic Mouthwash; Magic Mouthwash; Combination product: Salt and Baking soda rinse; Mouth rinse made with salt and baking soda; Drug: Carafate; Carafate taken as a slurry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of Oral Mucositis and Esophagitis	to determine whether to add oral aloe vera juice to standard of care treatments for lip, oral cavity, hard palate, tongue, tonsil , pharyngeal, laryngeal, neck , esophageal, mediastinal, and chest wall cancers will help prevent oral mucositis and esophagitis symptoms while patients undergo radiation therapy. Symptoms will be assessed using the CTCAE v. 5.0 weekly while on treatment to determine if the addition of aloe vera juice impacts these symptoms when compared to subjects that don't receive aloe vera juice.	10 weeks
Management of Oral Mucositis and Esophagitis	to determine whether to add oral aloe vera juice to standard of care treatments for lip, oral cavity, hard palate, tongue, tonsil , pharyngeal, laryngeal, neck , esophageal, mediastinal, and chest wall cancers will help manage oral mucositis and esophagitis symptoms while patients undergo radiation therapy. Symptoms will be assessed using the CTCAE v. 5.0 weekly while on treatment to determine if the addition of aloe vera juice impacts these symptoms when compared to subjects that don't receive aloe vera juice.	10 weeks

Collaborators and Investigators

• Sponsor: Thompson Cancer Survival Center
• Investigators: Principal Investigator: Daniel Scaperoth, MD, Thompson Cancer Survival Center

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Esophageal Diseases; Laryngeal Diseases; Mediastinal Diseases; Thoracic Diseases; Mucositis; Esophagitis; Mouth Neoplasms; Oropharyngeal Neoplasms; Stomatitis; Laryngeal Neoplasms; Mediastinal Neoplasms; Gastrointestinal Agents; Anti-Ulcer Agents; Sucralfate
• Other Study ID Numbers: 2022-404 INV Aloe_Oncology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data analysis will be shared upon completion of the study through a medical publication however at this time the exact plan and what documents is unknown.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes