What side effects are associated with this type of intervention?

Common treatments for mucositis with anti-inflammatory and healing properties, such as topical glucocorticoids, can cause side effects like oral candidiasis, taste disturbances, and mucosal thinning. Low-level laser therapy (LLLT) may cause mild discomfort, while hyperbaric oxygen therapy (HBO) can lead to ear pain or sinus issues. Aloe vera juice, which is being studied for its benefits in mucositis, is generally well-tolerated but may cause gastrointestinal upset in some individuals.

What prior FDA approvals exist?

The FDA has approved several treatments for mucositis, primarily focusing on their anti-inflammatory and healing properties. Palifermin (Kepivance) is a notable example, approved for decreasing the incidence and duration of severe oral mucositis in patients with hematologic malignancies undergoing high-dose chemotherapy and radiation. Additionally, Gelclair, a bioadherent oral gel, is used to manage oral mucositis pain by forming a protective barrier. These treatments aim to reduce inflammation and promote healing, similar to the effects being studied with aloe vera juice.

What other types of research exist?

Promising alternatives to Aloe Vera Juice for mucositis patients include low-level laser therapy (LLLT) and autologous platelet concentrates (APC). LLLT has shown potential in improving healing and symptoms, while APC has been evaluated for its benefits in oral surgery and wound healing.

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Aloe Vera Juice for Mucositis and Esophagitis

Phase 3

Waitlist Available

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

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing aloe vera juice to see if it can help cancer patients who have painful mouth and throat sores from chemotherapy and radiation. The juice is specially processed to avoid stomach issues. It aims to soothe and heal these sores, potentially improving patients' ability to eat and drink without needing treatment breaks. Aloe vera has been studied for its potential to treat various oral conditions, including chemotherapy-induced oral mucositis.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Management of Oral Mucositis and Esophagitis

Prevention of Oral Mucositis and Esophagitis

Awards & Highlights

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.

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

100% Aloe Vera Juice

2022

Completed Phase 3

~100

Sucralfate

FDA approved

Magic Mouthwash

2022

Completed Phase 3

~180

Sodium bicarbonate

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for mucositis, such as Aloe Vera Juice, work primarily through their anti-inflammatory and healing properties. Aloe Vera Juice helps reduce inflammation and pain, which are significant symptoms of mucositis. Its healing properties promote tissue regeneration and repair, essential for treating the ulcerations and lesions in the mucosal lining. These mechanisms are crucial as they not only alleviate the painful symptoms but also enhance the healing process, thereby significantly improving the quality of life for mucositis patients.