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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether 100% aloe vera juice can help manage oral mucositis and esophagitis, painful side effects of chemotherapy and radiation. Participants will either use aloe vera juice alongside standard treatments or rely on standard treatments alone. The goal is to determine if aloe vera juice noticeably reduces discomfort. This trial may suit individuals with certain types of cancer who are currently undergoing both chemotherapy and radiation. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aloe vera juice is generally safe for both oral use and consumption. In one study on oral use, only two participants experienced mild nausea, with no serious side effects reported. Another study found no side effects with similar use.

Regarding consumption, studies indicate that drinking aloe vera juice is usually safe. Animal tests showed no harmful effects. Aloe vera is also known to help reduce inflammation and heal wounds, with few side effects.

These findings suggest that aloe vera juice is safe for most people. However, individual responses can vary, so consulting a healthcare provider is advisable if there are any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using 100% aloe vera juice for mucositis and esophagitis because it offers a natural and soothing alternative to standard treatments like salt and baking soda rinses, Magic Mouthwash, and Carafate. Unlike these conventional options, aloe vera juice can be used either by swishing and spitting or by drinking, introducing flexibility in administration. Aloe vera is known for its anti-inflammatory and healing properties, which may provide relief and promote healing more naturally and gently than traditional chemical-based treatments. This novel approach could potentially reduce reliance on medication and offer a refreshing option for patients seeking complementary therapies.

What evidence suggests that aloe vera juice could be an effective treatment for mucositis and esophagitis?

Research has shown that aloe vera juice can help manage oral mucositis, a painful condition where the mouth lining becomes inflamed and develops sores, often due to chemotherapy or radiation. Studies have found that aloe vera juice can greatly reduce the severity of these symptoms. In one study, fewer patients experienced severe mucositis when using aloe vera compared to those who did not. Aloe vera juice, known for its natural soothing properties, may relieve discomfort from these treatments. This trial will evaluate the effectiveness of aloe vera juice in two different methods: swishing and spitting, or drinking, alongside standard care treatments. Although not all studies have found significant benefits, aloe vera remains a promising option for easing the painful symptoms of mucositis and esophagitis. ^{1 2 4 5 6}

Who Is on the Research Team?

Daniel Scaperoth, MD

Principal Investigator

Thompson Cancer Survival Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05369234

Effects of Oral Aloe Vera Juice on Chemotherapy and ... Several prior studies have shown the positive effects of oral use of aloe vera juice in managing chemotherapy and radiation-induced oral mucositis and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11132420/

Investigating the effect of Aloe vera on the prevention and ... This study evaluated the effect of Aloe vera on the prevention and treatment of radiotherapy-induced oral mucositis (RIOM) in patients with head-and-neck ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5028429/

Clinical Effectiveness of Aloe Vera in the Management ... The aim of the present systematic review was to compile evidence based studies on the effectiveness of Aloe vera in treatment of various oral diseases.

4. researchgate.net researchgate.net/publication/267721093_The_efficacy_of_oral_Aloe_vera_juice_for_radiation_induced_mucositis_in_head_and_neck_cancer_patients_A_double-blind_placebo-controlled_study

The efficacy of oral Aloe vera juice for radiation induced ... The incidence of severe mucositis was significantly lower in the aloe vera group compared with the placebo group (53% vs. 87%, p =0.004).

5. withpower.com withpower.com/trial/phase-3-esophagitis-2022-e29a8

Aloe Vera Juice 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 ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ors.12988

Efficacy of Aloe vera in Cancer‐Related Oral Mucositis: An ... Natural remedies have anti-inflammatory, antimicrobial and wound-healing properties at an affordable cost with minimal adverse effects in the ...