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IRCT201311015987N8 IRCT 2014-08-05 Tehran University of Medical Science The Effect of Oat Cream on skin reaction caused by radiotherapy. The assessment of Avena Sativa cream efficacy on skin reactions caused by radiotherapy in patients with breast cancer. 2014-05-22 anticipated 60 Complete https://irct.ir/trial/6452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. 2-3 Breast Cancer. Intervention 1: At the first time of beginning radiotherapy we will recommend to patients use the cream which prepared from oat extract, three times a day each 8 hours daily (TDS), in the radiotherapy area, amount of one finger (FTU) will be applied uniformly with the index finger ( considerably in different patients based on the extent of the lesion, this unit can be doubled) and for 3 hours, they must avoid washing the area. Intervention 2: In the control group patients will use placebo (extract-free cream base).
public Shahrzad ghiyasvandiyan
Faculty of Nursing & Midwifery, Tohid square
Tehran Iran (Islamic Republic of) +98 21 6642 0739 shghiyas@tums.ac.ir Tehran University of Medical Sciences,School of Nursing and Midwifery scientific Shahrzad ghiyasvandian
Faculty of Nursing & Midwifery, Tohid square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6642 0739 shghiyas@tums.ac.ir Tehran University of Medical Science/School of Nursing and Midwifery Iran (Islamic Republic of) Inclusion criteria: Women with breast cancer; Without any skin lesion. Exclusion criteria: Patients with uncontrolled diabetes; Acquired immunodeficiency syndrome; A history of allergy to medicinal plants. no limit no limit Female C50.9 Malignant Neoplasm of Breast Treatment - Drugs Placebo At the first time of beginning radiotherapy we will recommend to patients use the cream which prepared from oat extract, three times a day each 8 hours daily (TDS), in the radiotherapy area, amount of one finger (FTU) will be applied uniformly with the index finger ( considerably in different patients based on the extent of the lesion, this unit can be doubled) and for 3 hours, they must avoid washing the area. In the control group patients will use placebo (extract-free cream base). The grade of skin reaction caused by radioytherapy. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Using the RTOG questionnaire and researcher-made questionnaire. Erythema. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Using the RTOG questionnaire and researcher-made questionnaire. Dry desquamation. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Using the RTOG questionnaire and researcher-made questionnaire. Itching. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Ask the patient and using a researcher-made questionnaire. Burning sensation. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Ask the patient and using a researcher-made questionnaire. Changes in daily activities. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Ask the patient. Tenderness. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Ask the patient. Patchy and Distribution Moist Desquamation. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Examination by a physician. Drainage, Infection, Cellulitis. Timepoint: At the intervals of 10 days after initiation of treatment , 28 days after initiation of treatment, on the last day of radiotherapy and after that in two times with one week interval, after the end of radiotherapy participants will be followed up. Method of measurement: Examination by a physician. Tehran University of Medical Science Approved 2014-05-19 Research Deputy Tehran University of Medical Sciences sixth floor of the University Center, Qods St, Keshavarz Blvd. Tel: 88987382 - Fax: 88989664 Tehran Iran (Islamic Republic of)