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IRCT20190305042925N1 IRCT 2019-04-29 Tabriz University of Medical Sciences Investigating the Clinical Effects of Boron-based Gel on Restorative Dermatoses and Radiation Traumatic Causes Investigating the Clinical Effects of Boron Based Gel on the Prevention or Restoring of Radiotherapy Dermatitis in Neck, Head and Breast Cancer Patients 2019-02-05 anticipated 200 Complete https://irct.ir/trial/38046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Given the fact that the sample size is the same in both groups, we use the Excel software and the formula = Rand () to randomize and to increase the precision and balance of the samples in the randomization (for any reason Patient will withdraw from the plan) We use several blocks per group. It will also be provided to the physician to cover the allocation of matte envelopes, Blinding description: A gel that has an active ingredient in boron with a gel that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the gel used for the patient may be medication or medication. Clinicians and blind patients will be blinded. 3 Radiotherapy-induced dermatitis in patients with neck and head and breast cancers. Intervention 1: Control group: During each radiotherapy session, 15 minutes before radiotherapy, the gel will be free of any chemical treatments. Intervention 2: Intervention group: uring each radiation therapy session, 15 minutes before radiotherapy, 3% sodium will be used for pentahydrate panteoborate. Yes - There is a plan to make this available What will be shared: A portion of the data will be shared When: 2020 To whom: University researchers and professors Conditions: For further studies Where to obtain: via email How to obtain: Request via email Comments:
public Farshad Seyed Nejad
East Azerbaijan Province, Tabriz, Univesity Main St
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3335 9680 fnejad@gmail.com Tabriz University of Medical Sciences scientific Farshad Seyed Nejad
golgasht street
Tabriz Iran (Islamic Republic of) 5166/15731 +98 41 3335 9680 fnejad@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients who agree to enroll in the study Patients with head and neck and breast cancer who decide to use radiotherapy to spend time on chemotherapy. Patients older than 18 years of age and below 75 years Patients who have not received radiotherapy before 18 years 75 years Both Patients with cancer other than head and neck and breast Pregnant patients Patients with dermatitis regardless of cause L59.8 Other specified disorders of the skin and subcutaneous tissue related to radiation Placebo Treatment - Drugs Control group: During each radiotherapy session, 15 minutes before radiotherapy, the gel will be free of any chemical treatments. Intervention group: uring each radiation therapy session, 15 minutes before radiotherapy, 3% sodium will be used for pentahydrate panteoborate. RISR. Timepoint: 25 days. Method of measurement: FPHS. RTOG. Timepoint: 25 days. Method of measurement: FPHS. Tabriz University of Medical Sciences Approved 2019-02-04 Ethics Committee of Tabriz University of Medical Sciences Tabriz, Azadi St., Golghast St., Central building of Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)