]>
IRCT20131017015044N5 IRCT 2020-02-29 Mashhad University of Medical Sciences Evaluation effect of crocin in cardiac complication due to doxorubicin in patients with breast cancer Evaluation effect of crocin in cardiac complication due to doxorubicin in patients with breast cancer 2019-12-22 anticipated 60 Complete https://irct.ir/trial/45452 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: permuted block Randomization. In this study the sample size is 60. 15 blocks with 4 cases, in each block 2 of placebo group and 2 of intervention group will be randomly selected, Blinding description: Sequentially numbered, sealed, opaque envelopes. A random sequence will be created by random allocation rule. Then, based on the sample size, 60 envelopes with aluminum foil inside (to prevent ''hot lighting'') will be prepared. Each entity in the random sequence will be noted on a card and replaced in numbered envelop. Finally, the envelopes will be sealed and placed in boxes, respectively. The envelops are going to respectively assign to each participant so the participant's assigned group will be revealed. 3 Breast cancer. Intervention 1: Intervention group: Adding crocin to chemotherapy regimen containing doxorubicin. In the intervention group, patients will receive two capsules of 15 mg crocin daily along with chemotherapy drugs. The duration of the consumption will be 4 months. Intervention 2: Control group: chemotherapy regimen containing doxorubicin with placebo. In the control group, patients will receive two capsules daily, similar in appearance to the capsules of crocin, along with chemotherapy drugs. The duration of consumption will be 4 months. 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 The research may be continued and the final results will be reported
public Fatemeh Molaei
Omid Hospital, Alandasht intersection, Koohsangi Street
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3846 1518 MolaeiF961@mums.ac.ir Mashhad University of Medical Sciences scientific Soodabeh Shahidsales
Omid Hospital, Alandasht intersection, Koohsangi Street
Mashhad Iran (Islamic Republic of) 9176613775 +98 51 3846 1518 Shahidsaless@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Non metastatic breast cancer female patient candidate for adjuvant chemotherapy along with regimen containing doxorubicin Negative HER2 receptor 25 years 70 years Female Unwillingness to enter the study History of taking psychiatric drugs (anti-anxiety drugs and Anti-depressant ) Psychiatric disorders Underlying heart disease heart valve disease C50.9 Malignant neoplasm of breast of unspecified site Treatment - Drugs Placebo Intervention group: Adding crocin to chemotherapy regimen containing doxorubicin. In the intervention group, patients will receive two capsules of 15 mg crocin daily along with chemotherapy drugs. The duration of the consumption will be 4 months. Control group: chemotherapy regimen containing doxorubicin with placebo. In the control group, patients will receive two capsules daily, similar in appearance to the capsules of crocin, along with chemotherapy drugs. The duration of consumption will be 4 months. Complications of heart failure (shortness of breath, reduced EF ). Timepoint: before treatment and 2.5 and 5 months after treatment. Method of measurement: Echocardiography-Electrocardiography- TPI -ProBNP. Other cardiac complications (ischemia). Timepoint: before treatment and 2.5 and 5 months after treatment. Method of measurement: Echocardiography-Electrocardiography- TPI -ProBNP. Mashhad University of Medical Sciences Approved 2019-08-27 Ethics committee of Mashhad university of Medical Sciences Second Floor, Ghoreishi Building, Daneshgah Street, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)