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


Phase 3
18 Years
85 Years
Not Enrolling
Both
Radiation Dermatitis

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Safety Issue:

No

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

Oncoclinica-2009-02

NCT ID:

NCT00876642

Start Date:

March 2007

Completion Date:

December 2008

Related Keywords:

  • Radiation Dermatitis
  • Radiation dermatitis
  • best supportive care
  • Aloe vera gel
  • phase III study was to assess the effectiveness of aloe vera and vitamin E.
  • Dermatitis
  • Radiodermatitis

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