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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Thompson Cancer Survival Center Radiation Oncology Services | Knoxville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Thompson Cancer Survival Center |
United States,
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 |
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