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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369234
• Other study ID #: 2022-404 INV Aloe_Oncology
• Status: Recruiting
• Phase: Phase 3
• Start date: January 20, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: Thompson Cancer Survival Center
• Contact: Amanda Mondini, RD, LDN
• Phone: 865-331-1757
• Email: amondini[@]covhlth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chest Wall Tumor
• Esophageal Cancer
• Esophagitis
• Laryngeal Cancer
• Laryngeal Neoplasms
• Mediastinal Cancer
• Mediastinal Neoplasms
• Mouth Neoplasms
• Mucositis
• Oral Cavity Cancer
• Oropharyngeal Neoplasms
• Oropharynx Cancer
• Radiation Mucositis
• Stomatitis

Intervention

Dietary Supplement:
• 100% Aloe Vera Juice
George's 100% Aloe Vera Liquid Supplement

Combination Product:
• Magic Mouthwash
Magic Mouthwash
• Salt and Baking soda rinse
Mouth rinse made with salt and baking soda

Drug:
• Carafate
Carafate taken as a slurry

Locations

Country	Name	City	State
United States	Thompson Cancer Survival Center Radiation Oncology Services	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Thompson Cancer Survival Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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