Status:
COMPLETED
Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis
Lead Sponsor:
Thompson Cancer Survival Center
Conditions:
Oral Cavity Cancer
Head and Neck Cancers - Tonsils
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05369234
Start Date
January 20 2022
End Date
January 30 2024
Last Update
October 10 2024
Active Locations (1)
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1
Thompson Cancer Survival Center Radiation Oncology Services
Knoxville, Tennessee, United States, 37916