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Aloe Vera Juice for Mucositis and Esophagitis
Phase 3
Recruiting
Led By Daniel Scaperoth, MD
Research Sponsored by Thompson Cancer Survival Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study Summary
This trial will test the effects of aloe vera juice on mucositis and esophagitis caused by chemo and radiation.
Who is the study for?
This trial is for adults over 18 with certain cancers (like lip, oral cavity, tongue, neck, esophageal) who are undergoing chemotherapy and radiation. They must consent to the study's terms and agree to use contraception. It excludes pregnant or breastfeeding women, those not on chemo and radiation therapy, or with psychiatric conditions affecting compliance.Check my eligibility
What is being tested?
The study tests if drinking Aloe Vera juice can help manage mouth sores and throat irritation caused by cancer treatments. Participants will also use other remedies like Magic Mouthwash and salt-baking soda rinse to compare effectiveness.See study design
What are the potential side effects?
Aloe Vera juice may cause digestive issues such as cramps or diarrhea in some people. The other interventions like Magic Mouthwash might lead to taste changes or a burning sensation in the mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Management of Oral Mucositis and Esophagitis
Prevention of Oral Mucositis and Esophagitis
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2--Arm 1Experimental Treatment4 Interventions
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
Group II: Cohort 1--Arm 1Experimental Treatment4 Interventions
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
Group III: Cohort 1--Arm 2Active Control3 Interventions
Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.
Group IV: Cohort 2-- Arm 2Active Control3 Interventions
Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magic Mouthwash
2015
Completed Phase 3
~80
Find a Location
Who is running the clinical trial?
Thompson Cancer Survival CenterLead Sponsor
3 Previous Clinical Trials
700 Total Patients Enrolled
Daniel Scaperoth, MDPrincipal InvestigatorThompson Cancer Survival Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with cancer in the lips, mouth, tongue, tonsils, throat, neck, esophagus, or chest area.You are 18 years old or older.You have had allergic reactions to substances similar to aloe vera juice.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1--Arm 1
- Group 2: Cohort 1--Arm 2
- Group 3: Cohort 2--Arm 1
- Group 4: Cohort 2-- Arm 2
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being recruited for this clinical trial?
"That is correct, the clinical trial is recruiting patients as the most recent information on clinicaltrials.gov indicates. The posting for the trial went up on 1/20/2022 and has been edited as recently as 5/5/2022. They are looking for 100 patients to participate at 1 location."
Answered by AI
Has the FDA cleared 100% Aloe Vera Juice for public consumption?
"There is some efficacy data and multiple rounds of safety data, so the 100% Aloe Vera Juice receives a score of 3."
Answered by AI
Is it possible to sign up for this experiment currently?
"The trial, which was published on 1/20/2022 and last edited on 5/5/2022, is detailed on clinicaltrials.gov and is currently looking for participants."
Answered by AI
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