In this clinical trial, patients with non-metastatic breast cancer who are candidate for receiving chemotherapy with doxorubicin-regimen (AC-TAXOL) will be entered in this research. The treatment regimen of these patients will be according to the oncologist's opinion according to standard protocols that crocin will be added to the regimen of intervention group. Patients will be randomly divided into two groups according to age, sex, stage of disease, etc. The first group will receive standard treatment with placebo and the second group will receive standard treatment with crocin. The daily dose of crocin will be 15 mg for 4 months. The total number of patients in this study will be 60 patients (30 patients per group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non metastatic breast cancer; female patient; candidate for adjuvant chemotherapy along with regimen containing doxorubicin; Negative HER2 receptor.
Exclusion criteria: Unwillingness to enter the study; History of taking psychiatric drugs (anti-anxiety drugs and Anti-depressant); Psychiatric disorders; Underlying heart disease; heart valve disease.
Intervention groups
In the intervention group, patients will receive two capsules of 15mg crocin daily while in the placebo group, patients will receive two capsules (placebo), similar in appearance and form to crocin capsules, along with chemotherapy. The duration of capsule use in both groups will be 4 months.
Main outcome variables
Complications of heart failure (shortness of breath, reduced EF )
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131017015044N5
Registration date:2020-02-29, 1398/12/10
Registration timing:registered_while_recruiting
Last update:2020-02-29, 1398/12/10
Update count:0
Registration date
2020-02-29, 1398/12/10
Registrant information
Name
Soodabeh Shahidsales
Name of organization / entity
Cancer research center
Country
Iran (Islamic Republic of)
Phone
+98 51 1846 1518
Email address
shahidsaless@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of crocin in cardiac complication due to doxorubicin in patients with breast cancer
Public title
Evaluation effect of crocin in cardiac complication due to doxorubicin in patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non metastatic breast cancer
female patient
candidate for adjuvant chemotherapy along with regimen containing doxorubicin
Negative HER2 receptor
Exclusion criteria:
Unwillingness to enter the study
History of taking psychiatric drugs (anti-anxiety drugs and Anti-depressant )
Psychiatric disorders
Underlying heart disease
heart valve disease
Age
From 25 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad university of Medical Sciences
Street address
Second Floor, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2019-08-27, 1398/06/05
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.670
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
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
Secondary outcomes
1
Description
Other cardiac complications (ischemia)
Timepoint
before treatment and 2.5 and 5 months after treatment
Method of measurement
Echocardiography-Electrocardiography- TPI -ProBNP
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Fatemeh Molaee
Street address
Omid Hospital, Alandasht intersection,Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
info@hospitalomid.com
Web page address
http://omid.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Khorasan Razavi, Mashhad, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
presidentoffice@mums.ac.ir
Web page address
https://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Molaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht intersection, Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
MolaeiF961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soodabeh Shahidsales
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht intersection, Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
Shahidsaless@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Molaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Omid Hospital, Alandasht intersection, Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3846 1518
Email
MolaeiF961@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available