NCT05369234|CompletedPhase 3FDA Drug
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Sponsor study identifier
interventional
100
1 country
1
Study Start
January 20, 2022
Actual (reported)Primary Completion
January 30, 2024
Actual (reported)Study Completion
January 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 20, 2022
Actual (reported)April 28, 2022
Actual (reported)May 11, 2022
Actual (reported)January 30, 2024
Actual (reported)January 30, 2024
Actual (reported)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
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
Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.
George's 100% Aloe Vera Liquid Supplement
Thompson Cancer Survival Center Radiation Oncology Services
Knoxville, Tennessee, 37916, United States
Daniel Scaperoth, MD
Covenant Health Cancer Center
100 participants (actual enrollment reported by the registry).
First Submitted
April 28, 2022
First Posted
May 11, 2022
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
Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.
Mouth rinse made with salt and baking soda
Contact the study team to confirm eligibility.
Study Start
January 20, 2022
Actual (reported)Primary Completion
January 30, 2024
Actual (reported)Study Completion
January 30, 2024
Actual (reported)Last Updated
October 10, 2024
Record last verified: 2024-10
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.
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Source: ClinicalTrials.gov.
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