Oral Cavity CancerPhase 3NCT05369234
Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis
A Phase 3 study testing 100% Aloe Vera Juice, Magic Mouthwash and Salt and Baking soda rinse in people with Oral Cavity Cancer and Head and Neck Cancers - Tonsils, run by Covenant Health Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cavity Cancer, Head and Neck Cancers - Tonsils, Esophageal Cancer
- What is being tested?
- 100% Aloe Vera Juice, Magic Mouthwash and Salt and Baking soda rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 30 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thompson Cancer Survival Center Radiation Oncology Services
Knoxville, Tennessee, 37916
About this study
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.
Read the 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.
- Conditions
- Oral Cavity Cancer, Head and Neck Cancers - Tonsils, Esophageal Cancer, Laryngeal Cancer, Oropharynx Cancer, Mediastinal Cancer
- Being tested
- 100% Aloe Vera Juice, Magic Mouthwash, Salt and Baking soda rinse, Carafate
- Medical subject headings
- Mouth Neoplasms, Esophageal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms, Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% Aloe Vera JuiceDietary supplement
George's 100% Aloe Vera Liquid Supplement
Magic MouthwashCombination product
Magic Mouthwash
Salt and Baking soda rinseCombination product
Mouth rinse made with salt and baking soda
CarafateDrug
Carafate taken as a slurry
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1--Arm 1 | Experimental | 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 Receives: Dietary Supplement: 100% Aloe Vera Juice; Combination Product: Magic Mouthwash; Combination Product: Salt and Baking soda rinse; Drug: Carafate |
| Cohort 1--Arm 2 | Active comparator | Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc. Receives: Combination Product: Magic Mouthwash; Combination Product: Salt and Baking soda rinse; Drug: Carafate |
| Cohort 2--Arm 1 | Experimental | 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 Receives: Dietary Supplement: 100% Aloe Vera Juice; Combination Product: Magic Mouthwash; Combination Product: Salt and Baking soda rinse; Drug: Carafate |
| Cohort 2-- Arm 2 | Active comparator | Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc. Receives: Combination Product: Magic Mouthwash; Combination Product: Salt and Baking soda rinse; Drug: Carafate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start20 Jan 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covenant Health Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Scaperoth, MD, Principal investigator, Covenant Health Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369234
- Sponsor's protocol ID
- 2022-404 INV Aloe_Oncology
- Status last verified
- Oct 2024
- First submitted
- 28 Apr 2022
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis: a Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05369234
- Acronym / sponsor ID
- 2022-404 INV Aloe_Oncology
- Conditions
- Oral Cavity Cancer, Head and Neck Cancers - Tonsils, Esophageal Cancer, Laryngeal Cancer, Oropharynx Cancer, Mediastinal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Covenant Health Cancer CenterUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1--Arm 1 | Experimental | Dietary Supplement: 100% Aloe Vera Juice, Combination Product: Magic Mouthwash, Combination Product: Salt and Baking soda rinse, Drug: CarafateAloe 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 |
| Cohort 1--Arm 2 | Active comparator | Combination Product: Magic Mouthwash, Combination Product: Salt and Baking soda rinse, Drug: CarafateStandard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc. |
| Cohort 2--Arm 1 | Experimental | Dietary Supplement: 100% Aloe Vera Juice, Combination Product: Magic Mouthwash, Combination Product: Salt and Baking soda rinse, Drug: CarafateAloe 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 |
| Cohort 2-- Arm 2 | Active comparator | Combination Product: Magic Mouthwash, Combination Product: Salt and Baking soda rinse, Drug: CarafateStandard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% Aloe Vera JuiceGeorge's 100% Aloe Vera Liquid Supplement | Dietary supplement | Cohort 1--Arm 1, Cohort 2--Arm 1 |
| Magic MouthwashMagic Mouthwash | Combination product | Cohort 1--Arm 1, Cohort 1--Arm 2, Cohort 2-- Arm 2, Cohort 2--Arm 1 |
| Salt and Baking soda rinseMouth rinse made with salt and baking soda | Combination product | Cohort 1--Arm 1, Cohort 1--Arm 2, Cohort 2-- Arm 2, Cohort 2--Arm 1 |
| CarafateCarafate taken as a slurry | Drug | Cohort 1--Arm 1, Cohort 1--Arm 2, Cohort 2-- Arm 2, Cohort 2--Arm 1 |
Primary outcome
Prevention of Oral Mucositis and Esophagitis
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Scaperoth, MD principal investigator
Covenant Health Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 100% Aloe Vera Juice, Magic Mouthwash and Salt and Baking soda rinse in people with Oral Cavity Cancer and Head and Neck Cancers - Tonsils, run by Covenant Health Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of Oral Mucositis and Esophagitis (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.