Status:
COMPLETED
Trial Comparing Best Supportive Care to Aloe Vera Gel
Lead Sponsor:
Marilia Medicine School
Conditions:
Radiation Dermatitis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years. Although initially used for the treatment of chest wall recurrences after mastectomy and for advanced inope...
Eligibility Criteria
Inclusion
- The women had to be 18 to 75 years of age with a nonmetastatic breast adenocarcinoma treated by either lumpectomy or mastectomy with or without adjuvant postoperative chemotherapy or hormonal treatment, and referred to the Department of Radiotherapy for postoperative radiotherapy. Concomitant chemotherapy was allowed.
Exclusion
- Women with bilateral cancer, patients who were allergic to either of the two agents, and pregnant women were excluded.
- No rash, ulceration, bleeding, or unhealed scar was allowed in the treatment area.
- Patients were excluded for: prior radiation therapy (RT), mastectomy, skin involvement by tumor, history of, or current connective tissue disorder, medical contraindication (allergy or sensitivity) to Aloevera or planned BSC, and inability to comply with treatment regime. The use of bolus was prohibited.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00876642
Start Date
March 1 2007
End Date
December 1 2008
Last Update
April 7 2009
Active Locations (1)
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1
Gustavo Viani
Marília, Sao Paulo\brazil, Brazil, 17501570