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IRCT20141102019783N4 IRCT 2019-01-13 Vice chancellor for research, Mashhad University of Medical Sciences Efficacy of using scalp cooling caps in prevention of chemotherapy-induced alopecia Mashhad Scalp Cooling Caps Evaluation of using scalp cooling caps in prevention of chemotherapy-induced alopecia 2015-03-21 anticipated 60 Complete https://irct.ir/trial/17609 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. 3 Breast malignancy. Intervention 1: Using Scalp Cooling Cap 30 minutes before, during and up to 2.5 hours after chemotherapy with "Adriamycin and Cyclophosphamide" in breast cancer. Intervention 2: Using Scalp Cooling Cap 30 minutes before, during and up to 1.5 hours after chemotherapy with "Paclitaxel 175 mg/m2" in breast cancer. Intervention 3: Using Scalp Cooling Cap 30 minutes before, during and up to 1 hour after chemotherapy with "Paclitaxel 80 mg/m2" in breast cancer. Intervention 4: Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Bleomycin - Etoposide - Cisplatin" in gonadal malignancy. Intervention 5: Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Epirubicin - Cyclophosphamide - Fluorouracil (5Fu)" in breast cancer. Intervention 6: Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Vincristine - Adriamycin - Cyclophosphamide" in soft tissue sarcoma. Intervention 7: Chemotherapy with "Adriamycin and Cyclophosphamide" in breast cancer without using scalp cooling cap. Intervention 8: Chemotherapy with "Paclitaxel 175 mg/m2" in breast cancer without using scalp cooling cap. Intervention 9: Chemotherapy with "Paclitaxel 80 mg/m2" in breast cancer without using scalp cooling cap. Intervention 10: Chemotherapy with "Bleomycin - Etoposide - Cisplatin" in gonadal malignancy without using scalp cooling cap. Intervention 11: Chemotherapy with "Epirubicin - Cyclophosphamide - Fluorouracil (5Fu)" in breast cancer without using scalp cooling cap. Intervention 12: Chemotherapy with "Vincristine - Adriamycin - Cyclophosphamide" in soft tissue sarcoma without using scalp cooling cap. 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 No decision has been made on how and when to publish the data
public Mitra Fazl Ersi
Omid hospital, Alandasht Sq., Koohsangi St.
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3846 1518 mitrafazlersi@gmail.com Mashhad University of Medical Sciences scientific Roham Salek
Omid hospital, Alandasht Sq., Koohsangi St.
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3846 1518 salekr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) consent for using the cap and filling on the questionnaire using chemotherapy regimens resulting in total alopecia including: 1. Doxorobicin plus cyclophosphamide followed by one of the Taxane drugs (in one, two or three-week regimens) 2. BEP regimen in gonadal malignanciy 3. FEC (5Fu-Epirubicin -cyclophosphamaid) regimen 4. VAC (vincristin-Doxorobicin -cyclophosphamaid) regimen in sarcomas performance higher than 70% age between 18 to 75 years 18 years 75 years Both Melanoma Blood malignancies Liver or kidney dysfunction Migraine History of cryoglobulinemia Systemic lupus erythematosus No consent for using the caps CD50 Malignant neoplasm of breast Other Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Using Scalp Cooling Cap 30 minutes before, during and up to 2.5 hours after chemotherapy with "Adriamycin and Cyclophosphamide" in breast cancer. Using Scalp Cooling Cap 30 minutes before, during and up to 1.5 hours after chemotherapy with "Paclitaxel 175 mg/m2" in breast cancer. Using Scalp Cooling Cap 30 minutes before, during and up to 1 hour after chemotherapy with "Paclitaxel 80 mg/m2" in breast cancer Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Bleomycin - Etoposide - Cisplatin" in gonadal malignancy. Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Epirubicin - Cyclophosphamide - Fluorouracil (5Fu)" in breast cancer. Using Scalp Cooling Cap 30 minutes before, during and up to 2 hours after chemotherapy with "Vincristine - Adriamycin - Cyclophosphamide" in soft tissue sarcoma. Chemotherapy with "Adriamycin and Cyclophosphamide" in breast cancer without using scalp cooling cap. Chemotherapy with "Paclitaxel 175 mg/m2" in breast cancer without using scalp cooling cap. Chemotherapy with "Paclitaxel 80 mg/m2" in breast cancer without using scalp cooling cap. Chemotherapy with "Bleomycin - Etoposide - Cisplatin" in gonadal malignancy without using scalp cooling cap. Chemotherapy with "Epirubicin - Cyclophosphamide - Fluorouracil (5Fu)" in breast cancer without using scalp cooling cap Chemotherapy with "Vincristine - Adriamycin - Cyclophosphamide" in soft tissue sarcoma without using scalp cooling cap. Alopecia. Timepoint: prior to each chemotherapy cycle. Method of measurement: visual inspection and questionnaire based on WHO alopecia grading. Headache. Timepoint: following every cycle of chemotherapy. Method of measurement: qestionnaire. Vice chancellor for research, Mashhad University of Medical Sciences Approved 2015-12-09 Regional Ethics Committee of Mashhad University of Medical Sciences Goreishi Building, Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)