IRCT20160706028815N4 IRCT 2018-04-29 Mashhad University of Medical Sciences Effect of Crocin in treatment of breast cancer Assessment of the effectiveness of addition of Crocin to doxorubicin containing chemotherapy regimen on survival of breast cancer patients 2018-03-21 anticipated 80 Complete https://irct.ir/trial/30791 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients with block randomization (1:1) will be allocated to treatment or placebo groups. First patients will be entered into one group based on sealed envelops and second patient will entered another group. Patients will be allocated to groups consecutively, Blinding description: This is a double blind study and the responsible physician for assessment of the clinical symptoms and imaging and patients are blind. An individual outside the study team will take responsibility for randomization to crocin and placebo. 2-3 Malignant neoplasm of breast. Intervention 1: Intervention group: The patients will be requested to take two crocin tablets daily for four months (each tablet contain 15 milligram crocin). The crocin tabletes will be produced in the pharmacy faculty of Mashhad University of Medical Sciences from saffron. Although, the doxorubicin-containing chemotherapy regimen -using standard chemotherapy protocols in treatment of breast cancer- will be selected and will be calculated based on body surface area and will be prescribed every two-three weeks. Intervention 2: Control group: The patients will be requested to take two placebo tablets daily for four months. The crocin tabletes will be produced in the pharmacy faculty of Mashhad University of Medical Sciences. Although, the doxorubicin-containing chemotherapy regimen -using standard chemotherapy protocols in treatment of breast cancer- will be selected and will be calculated based on body surface area and will be prescribed every two-three weeks. 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 further information