]>
IRCT20220601055055N1 IRCT 2022-07-02 Kashan University of Medical Sciences The effect of Chicory root extract on radiation therapy-induced dermatitis The effect of topical use of Chicory root extract gel on the incidence and severity of radiation therapy-induced dermatitis in breast cancer patients. 2022-07-01 anticipated 44 Complete https://irct.ir/trial/63965 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients who meet the inclusion criteria are consecutively entered into the study and coded, then they are randomly divided into 11 blocks of 4 using a (Sealed Envelope software program, London, UK) . In each block, two people will be randomly assigned to the intervention group and two people to the placebo group. The randomization process is done by the first researcher. The second researcher, who is involved in the daily sampling and evaluation of patients, is blinded to the placement of the individual in the intervention or placebo group, Blinding description: The first executor uses a software program (Sealed Envelope software, London, UK) to randomly place people based on 4 blocks in two intervention groups (22 people) and placebo (22 people) and a list of codes Creates a dedicated and randomly assigns each patient to the intervention group and placebo. The first performer of the study, according to the code assigned to the patient, delivers 100 g tubes containing chicory root extract or placebo gel, which is encoded, to the second performer to provide to the patients. The second executor has been blinded to the allocation of individuals in study groups and drug tubes. Due to the coding of the evaluator, the treatment team and the patient are blinded to being in the desired group. Also, the statistical analyzer will perform the analysis according to the codes without knowing the groups. 3 Radiodermatitis. Intervention 1: Intervention group: From the first day of radiation therapy to the end of it (for one month), the intervention group will use 3% chicory root extract gel topically twice a day topically in the area undergoing radiation therapy.Tubes of 100 g containing the mentioned gel have been prepared by the Medicinal Plants Research Center of Shahrekord University of Medical Sciences. Intervention 2: Control group: In the control group, from the first day of radiation therapy to the end of it (for one month), twice a day, placebo gel, which has similar appearance properties to chicory root extract gel; They will be used topically in the area under radiation therapy. Tubes of 100 g containing the mentioned gel have been prepared by the Medicinal Plants Research Center of Shahrekord University of Medical Sciences. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Fatemeh Jafari
Faculty of Nursing & Midwifery., Kashan University of Medical Sciences., Parastar Blvd., Qotb –e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 6633 fatemejafari@yahoo.com Kashan University of Medical Sciences scientific Fatemeh Sadat Izadi-Avanji
Faculty of Nursing & Midwifery., Kashan University of Medical Sciences., Parastar Blvd., Qotb –e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 6633 fs.izadi@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Tendency to participate in the study Giving informed consent Having breast cancer based on the diagnosis of an oncologist no limit no limit Female known allergy to chicory plant and medical contraindication to chicory extract Existence of an ulcerated ulcer or scar at the site of radiation therapy History of previous radiation therapy at the current treatment site History of breast reconstruction (prosthesis) Simultaneous chemotherapy L58.0 Acute radiodermatitis Prevention Prevention Intervention group: From the first day of radiation therapy to the end of it (for one month), the intervention group will use 3% chicory root extract gel topically twice a day topically in the area undergoing radiation therapy.Tubes of 100 g containing the mentioned gel have been prepared by the Medicinal Plants Research Center of Shahrekord University of Medical Sciences. Control group: In the control group, from the first day of radiation therapy to the end of it (for one month), twice a day, placebo gel, which has similar appearance properties to chicory root extract gel; They will be used topically in the area under radiation therapy. Tubes of 100 g containing the mentioned gel have been prepared by the Medicinal Plants Research Center of Shahrekord University of Medical Sciences. Radiodermatitis score in Radiation Therapy Oncology Group Scale (RTOG Scale). Timepoint: Daily (from the beginning of the study to the end of radiation therapy). Method of measurement: Radiation Therapy Oncology Group Scale (RTOG Scale). Kashan University of Medical Sciences Approved 2022-05-16 Ethics Committee in Biomedical Researches, Faculties of Nursing and Midwifery, Health and Allied Med Parastar Blvd., Ghotb Ravandi Blvd Kashan Isfehan Iran (Islamic Republic of)