Trial Comparing Best Supportive Care to Aloe Vera Gel

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StatusConcluído

Patrocinadores

Marilia Medicine School

ENSAIO CLÍNICO: NCT00876642

BioSeek: nct00876642

Palavras-chave

Resumo

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.

datas

Última verificação:	03/31/2009
Enviado pela primeira vez:	04/04/2009
Inscrição estimada enviada:	04/05/2009
Postado pela primeira vez:	04/06/2009
Última atualização enviada:	04/05/2009
Última atualização postada:	04/06/2009
Data real de início do estudo:	02/28/2007
Data Estimada de Conclusão Primária:	08/31/2008
Data Estimada de Conclusão do Estudo:	11/30/2008

Condição ou doença

Radiation Dermatitis

Intervenção / tratamento

Drug: 1

Fase

Fase 3

Grupos de Armas

Braço	Intervenção / tratamento
Experimental: 1	Drug: 1 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.
No Intervention: 2

Critério de eleição

Idades qualificadas para estudar	18 Years Para 18 Years
Sexos elegíveis para estudo	All
Aceita Voluntários Saudáveis	sim
Critério	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.

Resultado

Medidas de Resultado Primário

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

Medidas de Resultado Secundário

1. quality of life,interruptions of treatment and pain. [undefined]

Trial Comparing Best Supportive Care to Aloe Vera Gel

Palavras-chave

cancro da mama

cancro

dermatite

eritema

aloe

babosa

antineoplásico

quimioterapia