Trial Comparing Best Supportive Care to Aloe Vera Gel

Sponsor

Marilia Medicine School (Other)

Overall Status

Completed

CT.gov ID

NCT00876642

Collaborator

(none)

137

Enrollment

Location

Arms

21.1

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Dermatitis	Drug: Aloe vera gel	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

137 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Mar 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Aloe vera gel 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

Arm

Intervention/Treatment

Experimental: 1

Drug: Aloe vera gel

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.