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. 2013 Dec;38(4):293-300.

Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial

Mansour Ansari  1 , Dehsara Farzin, Ahmad Mosalaei, Shapour Omidvari, Niloofar Ahmadloo, Mohammad Mohammadianpanah
Affiliations

Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial

Mansour Ansari et al. Iran J Med Sci. 2013 Dec.

Abstract

Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients.

Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy.

Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm(2) in the control arm and 17.02 cm(2) in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients' complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully.

Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer.

Trial registration numbers: IRCT201206099979N1, ACTRN12612000837820.

Keywords: Breast cancer; Hydrocortisone; Radiation-induced dermatitis; Radiotherapy.

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Figures

Figure 1
Figure 1
This is a depiction of the CONSORT flow diagram of 60 breast cancer patients, who developed chest wall radiation dermatitis
Figure 2
Figure 2
The rate of dermatitis healing time during 3 consecutive weeks of treatment is illustrated here
See this image and copyright information in PMC

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