Trial Comparing Best Supportive Care to Aloe Vera Gel

This study has been completed.
Sponsor:
Information provided by:
Marilia Medicine School
ClinicalTrials.gov Identifier:
NCT00876642
First received: April 5, 2009
Last updated: April 6, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Radiation Dermatitis
Drug: Aloe vera gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Marilia Medicine School:

Primary Outcome Measures:
  • Acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life,interruptions of treatment and pain. [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00876642

Locations
Brazil
Gustavo Viani
Marilia, Sao Paulo\brazil, Brazil, 17501570
Sponsors and Collaborators
Marilia Medicine School
  More Information

No publications provided

Responsible Party: Gustavo Viani Arruda, Marilia Medicine school
ClinicalTrials.gov Identifier: NCT00876642     History of Changes
Other Study ID Numbers: Oncoclinica-2009-02
Study First Received: April 5, 2009
Last Updated: April 6, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Marilia Medicine School:
Radiation dermatitis
best supportive care
Aloe vera gel
phase III study was to assess the effectiveness of aloe vera and vitamin E.

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014