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IRCT20230215057423N1 IRCT 2023-05-01 Shahre-kord University of Medical Sciences The effect of heparin gel in improving hand and foot syndrome in patients treated with capecitabine Survey the effect of topical heparin gel on the improvement of hand and foot syndrome in cancer patients treated with capecitabine 2023-04-30 anticipated 40 Complete https://irct.ir/trial/68605 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomize, the permutation block randomization method will be used. 7 blocks with a volume of 6 will be produced by RA software, each block will contain 3 letters A and 3 letters B, Blinding description: This study will be conducted in a double-blind manner, so that neither the patient nor the researcher is aware of the type of intervention. The placebo gel will be designed with a packaging and appearance completely similar to heparin gel and will be provided to the researcher in the form of coding. The researcher is also unaware of the contents of the packaging. As a result, the data will be collected and provided to the analyst. In order to randomize, the permutation block randomization method will be used. 7 blocks with a volume of 6 will be produced by RA software, each block will contain 3 letters A and 3 letters B. 3 cancer patient. Intervention 1: Intervention group: Intervention group: Group A as the intervention group, in addition to the standard chemotherapy treatment, will receive heparin sulfate gel 40 mg 4 times a day for 21 days. Intervention 2: Control group: Control group: Group B as a control group, in addition to the standard treatment, receive a placebo that looks like heparin gel. Yes - There is a plan to make this available What will be shared: To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published. When: The access period will start 6 months after the results are published. To whom: Our data will only be available to researchers working in academic and scientific institutions Conditions: If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data. Where to obtain: In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address maedemirjalili98@gmail.com or the contact number 00989132736651. How to obtain: To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most. Comments:
public Maede Mirjalili
Parastar
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3222 0016 maedemirjalili98@gmail.com Shahre-kord University of Medical Sciences scientific Maede Mirjalili
Parastar
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3222 0016 maedemirjalili98@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Newly diagnosed cancer patients for gastrointestinal tract and head and neck cancer treated with capecitabine and have evidence of early onset of hand-foot syndrome (grade 1 from onset) 18 years no limit Both The patient already has a skin or inflammatory disease The patient's unwillingness to start the trial C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck Treatment - Drugs Treatment - Other Intervention group: Intervention group: Group A as the intervention group, in addition to the standard chemotherapy treatment, will receive heparin sulfate gel 40 mg 4 times a day for 21 days. Control group: Control group: Group B as a control group, in addition to the standard treatment, receive a placebo that looks like heparin gel. Examination of erythema, blisters and hyperkeratosis in hand and foot syndrome. Timepoint: Day zero and day twenty one. Method of measurement: Questionnaire and observation. Shahre-kord University of Medical Sciences Approved 2022-09-14 Ethics Committee of Shahrekord University of Medical Sciences Parastar street Hajarhaspital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)