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Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis

Primary Purpose

Oral Cavity Cancer, Head and Neck Cancers - Tonsils, Esophageal Cancer

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
100% Aloe Vera Juice
Magic Mouthwash
Salt and Baking soda rinse
Carafate
Sponsored by
Thompson Cancer Survival Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Cavity Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Thompson Cancer Survival Center Radiation Oncology ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Cohort 1--Arm 1

Cohort 1--Arm 2

Cohort 2--Arm 1

Cohort 2-- Arm 2

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 28, 2022
Last Updated
May 5, 2022
Sponsor
Thompson Cancer Survival Center
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1. Study Identification

Unique Protocol Identification Number
NCT05369234
Brief Title
Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis
Official Title
Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis: a Single-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thompson Cancer Survival Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Oral mucositis and esophagitis are side effects of both chemotherapy and radiation that can interfere with a patient's ability to eat, drink, and maintain weight. They can significantly impact quality of life as well as creating the need for treatment breaks. Treatment breaks decrease the efficacy of treatment. A suspected method of treatment is aloe vera juice. 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. Aloe vera, or aloe barbadensis miller as it is known in the botanical world, is a succulent plant used in traditional medicine. In this study, the aloe vera juice that will be utilized by the patients is George's 100% Aloe Vera Juice, manufactured by Warren Laboratories. This aloe vera juice has been fractionally distilled to remove anthraquinone and other compounds that can cause nausea, abdominal cramping, and diarrhea, as well as bitter, unpleasant taste. 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, in combination with standard treatments, is more effective in management of oral mucositis and esophagitis than standard treatment alone. If so, aloe vera offers a natural, cost-effective option for managing radiation and chemotherapy side effects. Patients in arm 1 of cohort 1 or 2 will be given 3 gallons of George's 100% Aloe Vera Liquid Supplement, free of cost, to utilize throughout treatment. Patients in cohort 1, arm 2 will be asked to swish and spit ¼ cup (2 ounces) of the aloe vera juice 3 times per day, 7 days per week while they are on radiation treatment. Patients in cohort 2, arm 2 will be asked to drink ¼ cup (2 ounces) of aloe vera juice 3 times per day, 7 days per week while they are on chemotherapy and radiation treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity Cancer, Head and Neck Cancers - Tonsils, Esophageal Cancer, Laryngeal Cancer, Oropharynx Cancer, Mediastinal Cancer, Chest Wall Tumor, Radiation Mucositis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1--Arm 1
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 1--Arm 2
Arm Type
Active Comparator
Arm Description
Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.
Arm Title
Cohort 2--Arm 1
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2-- Arm 2
Arm Type
Active Comparator
Arm Description
Standard of Care Treatments Use salt and baking soda rinses, Magic Mouthwash, Carafate, etc.
Intervention Type
Dietary Supplement
Intervention Name(s)
100% Aloe Vera Juice
Intervention Description
George's 100% Aloe Vera Liquid Supplement
Intervention Type
Combination Product
Intervention Name(s)
Magic Mouthwash
Intervention Description
Magic Mouthwash
Intervention Type
Combination Product
Intervention Name(s)
Salt and Baking soda rinse
Intervention Description
Mouth rinse made with salt and baking soda
Intervention Type
Drug
Intervention Name(s)
Carafate
Intervention Description
Carafate taken as a slurry
Primary Outcome Measure Information:
Title
Prevention of Oral Mucositis and Esophagitis
Description
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.
Time Frame
10 weeks
Title
Management of Oral Mucositis and Esophagitis
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Mondini, RD, LDN
Phone
865-331-1757
Email
amondini@covhlth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chelsea Johnson, MS,RD,LDN
Phone
865-331-1757
Email
cjohns55@covhlth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Scaperoth, MD
Organizational Affiliation
Thompson Cancer Survival Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thompson Cancer Survival Center Radiation Oncology Services
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Mondini, RD, LDN
Phone
865-331-1757
Email
amondini@covhlth.com
First Name & Middle Initial & Last Name & Degree
Chelsea Johnson, MS.RD,LDN
Phone
865-331-1757
Email
cjohns55@covhlth.com
First Name & Middle Initial & Last Name & Degree
Daniel Scaperoth, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Effects of Oral Aloe Vera Juice on Chemotherapy and Radiation-induced Oral Mucositis and Esophagitis

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