Trial Comparing Best Supportive Care to Aloe Vera Gel

Alleen geregistreerde gebruikers kunnen artikelen vertalen

De link wordt op het klembord opgeslagen

ToestandVoltooid

Sleutelwoorden

Abstract

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.

Datums

Laatst geverifieerd:	03/31/2009
Eerste ingediend:	04/04/2009
Geschatte inschrijving ingediend:	04/05/2009
Eerst geplaatst:	04/06/2009
Laatste update ingediend:	04/05/2009
Laatste update geplaatst:	04/06/2009
Werkelijke startdatum van het onderzoek:	02/28/2007
Geschatte primaire voltooiingsdatum:	08/31/2008
Geschatte voltooiingsdatum van het onderzoek:	11/30/2008

Conditie of ziekte

Radiation Dermatitis

Interventie / behandeling

Drug: 1

Fase

Fase 3

Armgroepen

Arm	Interventie / behandeling
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

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie	18 Years Naar 18 Years
Geslachten die in aanmerking komen voor studie	All
Accepteert gezonde vrijwilligers	Ja
Criteria	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.

Resultaat

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Trial Comparing Best Supportive Care to Aloe Vera Gel

Sleutelwoorden

borstkanker

kanker

dermatitis

erytheem

aloë

aloë vera

antitumoraal middel

chemotherapie