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

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18+, Female
Study Type
Supportive care
NCD ID
NCT01824134
Protocol IDs
Study Sponsor
Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
NCI Full Details

Summary

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.

http://clinicaltrials.gov/ct2/show/NCT01824134?term=A+Phase+III+Double+Blind+Study+On+The+Efficacy+of+Topical+Aloe+Vera+Gel+on+Irradiated+Breast+Tissue&rank=1

Objectives

Primary Outcome Measures:
  • erythema [ Time Frame: one year ] [ Designated as safety issue: No ]
    since we are testing two over the counter products we wanted to wee if one tested better than the other

 

Secondary Outcome Measures:
  • itching [ Time Frame: one year ] [ Designated as safety issue: No ]
    is there a difference in itching