Aloe Vera on Irradiated Breast Tissue

NCT ID: NCT01824134

Last Updated: 2016-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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Conditions

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Irradiated Breast Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Klean & Klear

aloe vera gel

Group Type ACTIVE_COMPARATOR

Klean & Klear The Dandy Day Corp

Intervention Type OTHER

The Skin Gel

aloe vera gel

Group Type ACTIVE_COMPARATOR

The Skin Gel Herbal Answers, Inc

Intervention Type OTHER

Interventions

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Klean & Klear The Dandy Day Corp

Intervention Type OTHER

The Skin Gel Herbal Answers, Inc

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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John D. Archbold Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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J. Steven Johnson, MD

J. Steven Johnson, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital

Thomasville, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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12-09-008

Identifier Type: -

Identifier Source: org_study_id

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