Trial Comparing Best Supportive Care to Aloe Vera Gel
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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 |
- Acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer. [ Designated as safety issue: No ]
- 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 |
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 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 May 23, 2013