Aloe Vera on Irradiated Breast Tissue

A Phase III Double Blind Study on the Efficacy of Topical Aloe Vera Gel on Irradiated Breast Tissue

The investigators are testing two over the counter aloe veras on irradiated breast tissue.

Study Overview

• Status: Completed
• Conditions: Irradiated Breast Tissue
• Intervention / Treatment: Other: Klean & Klear The Dandy Day Corp; Other: The Skin Gel Herbal Answers, Inc

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Thomasville, Georgia, United States, 31792
      • Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. 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.
2. No major medical or psychiatric illness that might interfere with patient's completion of study requirements
3. Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

1. Those requiring nodal radiation therapy were excluded.
2. Subjects who have a breast infection at the commencement of radiation treatment
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Klean & Klear; aloe vera gel	Other: Klean & Klear The Dandy Day Corp
Active Comparator: The Skin Gel; aloe vera gel	Other: The Skin Gel Herbal Answers, Inc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: John D. Archbold Memorial Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 12-09-008