Trial Comparing Best Supportive Care to Aloe Vera Gel

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StatusLengkap

Sponsor

Marilia Medicine School

UJI KLINIS: NCT00876642

BioSeek: nct00876642

Kata kunci

Abstrak

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.

tanggal

Terakhir Diverifikasi:	03/31/2009
Pertama Dikirim:	04/04/2009
Perkiraan Pendaftaran Telah Dikirim:	04/05/2009
Pertama Diposting:	04/06/2009
Pembaruan Terakhir Dikirim:	04/05/2009
Pembaruan Terakhir Diposting:	04/06/2009
Tanggal Mulai Studi Sebenarnya:	02/28/2007
Perkiraan Tanggal Penyelesaian Utama:	08/31/2008
Perkiraan Tanggal Penyelesaian Studi:	11/30/2008

Kondisi atau penyakit

Radiation Dermatitis

Intervensi / pengobatan

Drug: 1

Tahap

Tahap 3

Kelompok Lengan

Lengan	Intervensi / pengobatan
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

Kriteria kelayakan

Usia yang Layak untuk Belajar	18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk Belajar	All
Menerima Relawan Sehat	Iya
Kriteria	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.

Hasil

Ukuran Hasil Utama

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

Ukuran Hasil Sekunder

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

Trial Comparing Best Supportive Care to Aloe Vera Gel

Kata kunci

kanker payudara

kanker

dermatitis

eritema infektiosum

aloe

lidah buaya

antikanker

kemoterapi