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Aloe Vera on Irradiated Breast Tissue

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01824134
Enrollment
40
Registered
2013-04-04
Start date
2012-10-31
Completion date
2014-03-31
Last updated
2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irradiated Breast Tissue

Brief summary

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

Interventions

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

Sponsors

John D. Archbold Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
erythemaone yearsince we are testing two over the counter products we wanted to wee if one tested better than the other

Secondary

MeasureTime frameDescription
itchingone yearis there a difference in itching

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026