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OpenTrials
Completed

NCT Number: NCT01824134

Aloe Vera on Irradiated Breast Tissue

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Thomasville, Georgia, 31792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Klean & Klear The Dandy Day Corp

Other

The Skin Gel Herbal Answers, Inc

Other

Primary outcomes

  1. erythema

    Time frame: one year

    since we are testing two over the counter products we wanted to wee if one tested better than the other

Secondary outcomes

  1. itching

    Time frame: one year

    is there a difference in itching

Sponsors and collaborators

Lead sponsor

John D. Archbold Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2013
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.