Oral Cavity Cancer, Head and Neck Cancers - Tonsils, Esophageal Cancer, Laryngeal Cancer, Oropharynx Cancer, Mediastinal Cancer, Chest Wall Tumor, Radiation Mucositis
Conditions
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 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.
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 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.
Interventions
DIETARY_SUPPLEMENT100% Aloe Vera Juice
George's 100% Aloe Vera Liquid Supplement
COMBINATION_PRODUCTMagic Mouthwash
Magic Mouthwash
COMBINATION_PRODUCTSalt and Baking soda rinse
Mouth rinse made with salt and baking soda
DRUGCarafate
Carafate taken as a slurry
Sponsors
Thompson Cancer Survival Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of Oral Mucositis and Esophagitis | 10 weeks | 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. |
| Management of Oral Mucositis and Esophagitis | 10 weeks | 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. |
Countries
United States
Outcome results
None listed