Aloe Vera on Irradiated Breast Tissue

John D. Archbold Memorial Hospital

Status and phase: Completed; Phase 3

Conditions: Irradiated Breast Tissue

Treatments: Other: The Skin Gel Herbal Answers, Inc; Other: Klean & Klear The Dandy Day Corp

Study type: Interventional

Funder types: Other

Identifiers

NCT01824134

12-09-008

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Klean & Klear

Active Comparator group

Description:

aloe vera gel

Treatment:

Other: Klean & Klear The Dandy Day Corp

The Skin Gel

Active Comparator group

Description:

aloe vera gel

Treatment:

Other: The Skin Gel Herbal Answers, Inc