Trial Comparing Best Supportive Care to Aloe Vera Gel

NCT00876642 — Phase 3, Completed, 137 participants, Marilia Medicine School

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Phase III Trial Comparing Best Supportive Care to Aloe Vera Gel as a Prophylactic Agent for Radiation Induced Skin Toxicity

Registry	NCT00876642
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	137 (Actual)
Sponsor	Marilia Medicine School (Other)
Conditions	Radiation Dermatitis
Interventions	Aloe vera gel (Drug)
Dates	start 2007-03-01, primary completion 2008-09-01, completion 2008-12-01, first posted 2009-04-07, last updated 2009-04-07
Locations	1 site in Brazil

-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 inoperable disease, RT has evolved into a critical component of early therapy for women with an intact breast following lumpectomy and for mastectomized women who are at high risk for local failure. Currently breast cancer patients need a multidisciplinary management including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco regional control of the disease. It is estimated that 87% of these women will develop some degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist desquamation.

Topical agents, such as corticosteroid creams and other products including Aquaphor (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of radiotherapy.

The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream for the prevention of acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary objectives were to assess pain, treatment interruption as a result of skin reactions, and the quantity of life during the treatment.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Experimental	Drug: Aloe vera gel
2	No intervention

Aloe vera gel (Drug): The aloe vera gel which was commercially available, contained water, aloe vera, D-panthenol, triethanolamine, carbomer 934P, hyaluronic acid, potassium sorbate, diazolidinyl urea, methylparaben, and propylparaben.

+Outcome measures

Primary outcomes

Acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer.

Secondary outcomes

quality of life,interruptions of treatment and pain.

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* 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 Criteria:

* 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.

+Locations (1)

Facility	City	Country	Status
Gustavo Viani	Marília, Sao Paulo\brazil	Brazil