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Trial Comparing Best Supportive Care to Aloe Vera Gel

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Marilia Medicine School

关键词

抽象

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.

日期

最后验证: 03/31/2009
首次提交: 04/04/2009
提交的预估入学人数: 04/05/2009
首次发布: 04/06/2009
上次提交的更新: 04/05/2009
最近更新发布: 04/06/2009
实际学习开始日期: 02/28/2007
预计主要完成日期: 08/31/2008
预计完成日期: 11/30/2008

状况或疾病

Radiation Dermatitis

干预/治疗

Drug: 1

相 3

手臂组

干预/治疗
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

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

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.

结果

主要结果指标

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

次要成果指标

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

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