Aloe Vera Juice for Mucositis and Esophagitis

Overseen By Amanda Mondini, RD, LDN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Thompson Cancer Survival Center

Disqualifiers: No chemotherapy/radiation, Allergies, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is Aloe Vera Juice safe for human consumption?

Research shows that decolorized Aloe vera juice, which has had certain compounds removed, is generally safe for consumption in rats, with no adverse effects observed in studies lasting up to 3 months. However, whole-leaf Aloe vera extract has been linked to intestinal irritation and cancer in rats, so it's important to ensure the product is decolorized and purified. ^{1 2 3 4 5}

How does Aloe Vera Juice differ from other treatments for mucositis and esophagitis?

Aloe Vera Juice is unique because it is a natural remedy that has shown effectiveness in reducing the severity of oral mucositis caused by chemotherapy, as seen in children with leukemia. Unlike standard treatments, it is applied topically and may offer a gentler alternative with fewer side effects. ^{1 6 7 8 9}

Research Team

Daniel Scaperoth, MD

Principal Investigator

Thompson Cancer Survival Center

Eligibility Criteria

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.

Inclusion Criteria

Must have signed and dated an IRB approved consent form that conforms to federal and institutional guidelines

You have been diagnosed with cancer in the lips, mouth, tongue, tonsils, throat, neck, esophagus, or chest area.

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

Exclusion Criteria

Patients who are not on concurrent chemotherapy and radiation

Patients with psychiatric illness/social situations that would limit compliance with study requirements

Pregnant women or women who are breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aloe vera juice in combination with standard treatments to manage oral mucositis and esophagitis during chemotherapy and radiation

10 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 100% Aloe Vera Juice

Trial Overview 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.

Participant Groups

Group I: Cohort 2--Arm 1 Experimental Treatment 4 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 1 Experimental Treatment 4 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 2 Active Control 3 Interventions

Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.

Group IV: Cohort 2-- Arm 2 Active Control 3 Interventions

Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.

Who Is Running the Clinical Trial?

Thompson Cancer Survival Center

Lead Sponsor

Trials

4

Recruited

800+

Findings from Research

Aloe vera whole-leaf extract was found to cause goblet cell hyperplasia and intestinal irritation in both F344/N rats and B6C3F1 mice after 13 weeks of exposure, indicating potential safety concerns.

Long-term studies revealed that Aloe vera extract is a carcinogen in the large intestine of F344/N rats, with increased incidences of tumors in higher dose groups, while no such tumors were found in mice or at lower doses in rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clear evidence of carcinogenic activity by a whole-leaf extract of Aloe barbadensis miller (aloe vera) in F344/N rats. Boudreau, MD., Mellick, PW., Olson, GR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clear evidence of carcinogenic activity by a whole-leaf extract of Aloe barbadensis miller (aloe vera) in F344/N rats. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The absence of genotoxicity of Aloe vera beverages: A review of the literature. [2023]

3. Egypt pubmed.ncbi.nlm.nih.gov

Toxicologic assessment of a commercial decolorized whole leaf aloe vera juice, lily of the desert filtered whole leaf juice with aloesorb. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Safety of purified decolorized (low anthraquinone) whole leaf Aloe vera (L) Burm. f. juice in a 3-month drinking water toxicity study in F344 rats. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Safety evaluation of supercritical carbon dioxide extract of Aloe vera gel. [2014]

6. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of Aloe vera syrup for the treatment of gastroesophageal reflux disease: a pilot randomized positive-controlled trial. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

[Off-label use of Budesonide suspensions to treat a patient with lymphocytic esophagitis]. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Biologically active constituents of leaves and roots of Aloe arborescens var. natalensis. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of Aloe-Vera Use for Prevention of Chemotherapy-Induced Oral Mucositis in Children with Acute Lymphoblastic Leukemia: A Randomized Controlled Clinical Trial. [2021]