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Study aim
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Determining effect of oral zinc sulfate on the prevention and treatment of radiotherapy-induced acute dermatitis in patients with breast cancer
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Design
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study include 150 patients who will be randomly divided into 3 groups A, B, C using a table of random numbers. The drugs are similar in appearance and method of use and the study is double-blind . method of blinding : none of the patients, physician and statistical analyst will be aware of the type of intervention performed.
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Settings and conduct
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afzalipour hospital, radiotherapy center
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Participants/Inclusion and exclusion criteria
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INCLUSION: Patients at least 18 years old, KPS score more than 70 , non-inflammatory breast cancer who candidates for whole breast RT
exclusion: history of radiation to the breast or chest, inflammatory breast lesion , reconstructive breast surgery, bilateral breast cancer, diabetes, and patients taking antioxidant supplements or a history of known gastrointestinal disease will not be included .
Other exclusion criteria include active connective tissue disease, scarring without healing due to previous surgery. Before entering to the study, informed written consent will be obtained from them. If patients are not satisfied will be excluded from the study
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Intervention groups
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Group A: This group will be treated with a dose of 220 mg
oral zinc sulfate (Alhavipharm), 3 times a day every 8 hours throughout the treatment. Group B: In this group, they will receive 220 mg oral zinc sulfate (Alhavipharm) twice a day and one placebo, every 8 hours. Group C: This group of patients is the control group and will receive placebo (Behsaz Arshian Daroo) for the whole time, which is completely similar in appearance but lacks the active ingredient of zinc sulfate capsule 3 times a day every 8 hours.
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Main outcome variables
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Degree of dermatitis
Need for narcotics to reduce burn pain during treatment
dermatitis site