NCT05369234

Brief 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. The intention is to determine whether aloe vera juice should be considered as part of standard treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

April 28, 2022

Last Update Submit

October 9, 2024

Conditions

Oral Cavity CancerHead and Neck Cancers - TonsilsEsophageal CancerLaryngeal CancerOropharynx CancerMediastinal CancerChest Wall TumorRadiation Mucositis

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    10 weeks

Study Arms (4)

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

Dietary Supplement: 100% Aloe Vera JuiceCombination Product: Magic MouthwashCombination Product: Salt and Baking soda rinseDrug: Carafate

Cohort 1--Arm 2

ACTIVE COMPARATOR

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

Combination Product: Magic MouthwashCombination Product: Salt and Baking soda rinseDrug: 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

Dietary Supplement: 100% Aloe Vera JuiceCombination Product: Magic MouthwashCombination Product: Salt and Baking soda rinseDrug: Carafate

Cohort 2-- Arm 2

ACTIVE COMPARATOR

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

Combination Product: Magic MouthwashCombination Product: Salt and Baking soda rinseDrug: Carafate

Interventions

100% Aloe Vera JuiceDIETARY_SUPPLEMENT

George's 100% Aloe Vera Liquid Supplement

Cohort 1--Arm 1Cohort 2--Arm 1
Magic MouthwashCOMBINATION_PRODUCT

Magic Mouthwash

Cohort 1--Arm 1Cohort 1--Arm 2Cohort 2-- Arm 2Cohort 2--Arm 1
Salt and Baking soda rinseCOMBINATION_PRODUCT

Mouth rinse made with salt and baking soda

Cohort 1--Arm 1Cohort 1--Arm 2Cohort 2-- Arm 2Cohort 2--Arm 1
CarafateDRUG

Carafate taken as a slurry

Cohort 1--Arm 1Cohort 1--Arm 2Cohort 2-- Arm 2Cohort 2--Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thompson Cancer Survival Center Radiation Oncology Services

Knoxville, Tennessee, 37916, United States

Location

MeSH Terms

Conditions

Mouth NeoplasmsEsophageal NeoplasmsLaryngeal NeoplasmsOropharyngeal NeoplasmsMediastinal Neoplasms

Interventions

SaltsSucralfate

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesOtorhinolaryngologic NeoplasmsLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsOtorhinolaryngologic DiseasesPharyngeal NeoplasmsPharyngeal DiseasesThoracic NeoplasmsMediastinal DiseasesThoracic Diseases

Intervention Hierarchy (Ancestors)

Inorganic ChemicalsThioglycosidesSulfur CompoundsOrganic ChemicalsSucroseDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Daniel Scaperoth, MD

    Covenant Health Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 11, 2022

Study Start

January 20, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
CSR

Locations

US(1)