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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2024-01-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Oral Cavity Cancer Head and Neck Cancers - Tonsils Esophageal Cancer Laryngeal Cancer Oropharynx Cancer Mediastinal Cancer Chest Wall Tumor Radiation Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

100% Aloe Vera Juice

Intervention Type DIETARY_SUPPLEMENT

George's 100% Aloe Vera Liquid Supplement

Magic Mouthwash

Intervention Type COMBINATION_PRODUCT

Magic Mouthwash

Salt and Baking soda rinse

Intervention Type COMBINATION_PRODUCT

Mouth rinse made with salt and baking soda

Carafate

Intervention Type DRUG

Carafate taken as a slurry

Cohort 1--Arm 2

Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.

Group Type ACTIVE_COMPARATOR

Magic Mouthwash

Intervention Type COMBINATION_PRODUCT

Magic Mouthwash

Salt and Baking soda rinse

Intervention Type COMBINATION_PRODUCT

Mouth rinse made with salt and baking soda

Carafate

Intervention Type DRUG

Carafate taken as a slurry

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

Group Type EXPERIMENTAL

100% Aloe Vera Juice

Intervention Type DIETARY_SUPPLEMENT

George's 100% Aloe Vera Liquid Supplement

Magic Mouthwash

Intervention Type COMBINATION_PRODUCT

Magic Mouthwash

Salt and Baking soda rinse

Intervention Type COMBINATION_PRODUCT

Mouth rinse made with salt and baking soda

Carafate

Intervention Type DRUG

Carafate taken as a slurry

Cohort 2-- Arm 2

Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.

Group Type ACTIVE_COMPARATOR

Magic Mouthwash

Intervention Type COMBINATION_PRODUCT

Magic Mouthwash

Salt and Baking soda rinse

Intervention Type COMBINATION_PRODUCT

Mouth rinse made with salt and baking soda

Carafate

Intervention Type DRUG

Carafate taken as a slurry

Interventions

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100% Aloe Vera Juice

George's 100% Aloe Vera Liquid Supplement

Intervention Type DIETARY_SUPPLEMENT

Magic Mouthwash

Intervention Type COMBINATION_PRODUCT

Salt and Baking soda rinse

Mouth rinse made with salt and baking soda

Intervention Type COMBINATION_PRODUCT

Carafate

Carafate taken as a slurry

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No