Aloe Vera on Irradiated Breast Tissue | NCT01824134

Studies
Aloe Vera on Irradiated Breast Tissue

NCT01824134

Sponsor

John D. Archbold Memorial Hospital

Status

Completed

Last Update Posted

Sep 19, 2016Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Irradiated Breast Tissue

Interventions

Klean & Klear The Dandy Day Corp
The Skin Gel Herbal Answers, Inc

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Apr 1, 2013

First Submission Date that Met QC Criteria

Apr 3, 2013

First Posted Date

Apr 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2016

Last Update Posted Date

Sep 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

J. Steven Johnson, MD, J. Steven Johnson, MD, John D. Archbold Memorial HospitalPrincipal Investigator

Lead Sponsor

John D. Archbold Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Klean & Klear	Active Comparator	aloe vera gel	Other: Klean & Klear The Dandy Day Corp
The Skin Gel	Active Comparator	aloe vera gel	Other: The Skin Gel Herbal Answers, Inc

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Klean & Klear The Dandy Day Corp	Other		Klean & Klear
The Skin Gel Herbal Answers, Inc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
erythema	since we are testing two over the counter products we wanted to wee if one tested better than the other	one year

Secondary Outcomes

Measure	Description	Time Frame
itching	is there a difference in itching	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women over 18 years of age who had undergone lumpectomy or partial mastectomy for breast cancer, and who then received postoperative radiation therapy using tangential fields, with or without a boost to the tumor bed. Chemotherapy as part of the treatment regimen was acceptable.
No major medical or psychiatric illness that might interfere with patient's completion of study requirements
Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

Those requiring nodal radiation therapy were excluded.
Subjects who have a breast infection at the commencement of radiation treatment
Before randomization, subjects who have agreed to participate are asked if they are allergic to any topical preparation. Those allergic to aloe vera were ineligible.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital		Thomasville	Georgia	31792	United States