This study will be done as a double-blind, randomized, placebo-controlled, clinical trial to determine Crocin treatment effects added to doxorubicin-contained chemotherapy in breast cancer.
Design
This study will be performed on 80 new breast cancer patients after margin negative surgery. Patients will be randomized to crocin or placebo during chemotherapy. In crocin group patients will take two 15 mg tablets daily and in placebo group, pills will be similar to crocin. Treatment length will be 4 months. Before each chemotherapy kidney function test and cellular blood count will be checked. Beck depression and anxiety tests will be taken before the beginning and after chemotherapy treatment and then every 4 months until one year. Besides, the presence and severity of chemotherapy side effects will be adopted from patients profiles. Patients will also be followed up for 3 years.
Settings and conduct
This study will be conducted in oncology clinic of Omid Hospital and Emam Reza Hospital, Mashhad. The responsible physician for assessment of imaging and clinical response and the patients will be blinded to the groups of patients.
Participants/Inclusion and exclusion criteria
The main inclusion criteria include patients with newly diagnosed invasive breast cancer that their diagnosis is confirmed by histologic evaluation and that are candidates for doxorubicin chemotherapy aged between 18-70 year old and in Karnofsky Performance Scale Index more than 70%. The main exclusion criteria include previous history of poor-control comorbidities, warfarin usage and anti-depression and anti-anxiety drugs usage.
Intervention groups
Patients will take two 15 milligram tablets per day In the crocin group, and two placebo tablets identical to crocin in the placebo group besides chemotherapy.
Main outcome variables
The primary endpoints of study are overall survival and progression free survival.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160706028815N4
Registration date:2018-04-29, 1397/02/09
Registration timing:registered_while_recruiting
Last update:2018-04-29, 1397/02/09
Update count:0
Registration date
2018-04-29, 1397/02/09
Registrant information
Name
Seyed Alireza Javadinia
Name of organization / entity
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2736
Email address
javadiniaa941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effectiveness of addition of Crocin to doxorubicin containing chemotherapy regimen on survival of breast cancer patients
Public title
Effect of Crocin in treatment of breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed invasive breast cancer
The Karnofsky Performance Scale Index equal to or more than 70%
doxorubicin containing chemotherapy regimen
Unilateral breast cancer
Age between 18 to 70 years old
Exclusion criteria:
chronic liver failure
chronic kidney failure
chronic heart failure
previous history of hematologic malignancies
History of taking Psychiatric drugs
Warfarin usage
Bipolar mood disorder
Evidence of metastasis
Age
From 18 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
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
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2017-11-01, 1396/08/10
Ethics committee reference number
IR.MUMS.fm.REC.1396.359
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of breast
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Overall Survival
Timepoint
Every 3 months in the first year, every 4-6 months in the second year, every 6 months in third to fifth years and then annually
Method of measurement
visit
2
Description
Progression-free Survival
Timepoint
Every 3 months in the first year, every 4-6 months in the second year, every 6 months in third to fifth years and then annually
Method of measurement
Visit
Secondary outcomes
1
Description
Anemia
Timepoint
Before each session of chemotherapy every two to three weeks
Method of measurement
laboratory assessment of Complete blood count
2
Description
Neutropenia
Timepoint
Before each session of chemotherapy every two to three weeks
Method of measurement
laboratory assessment of Complete blood count
3
Description
Thrombocytopenia
Timepoint
Before each session of chemotherapy every two to three weeks
Method of measurement
laboratory assessment of Complete blood count
4
Description
Alopecia
Timepoint
Before each session of chemotherapy every two to three weeks
Method of measurement
physical examination
5
Description
Nausea
Timepoint
Before each session of chemotherapy every two to three weeks
Method of measurement
history taking
6
Description
vomiting
Timepoint
Before each session of chemotherapy every two to three weeks
Method of measurement
history taking
7
Description
Depression
Timepoint
In the first visit and then every four months
Method of measurement
Beck's Depression Inventory
8
Description
Anxiety
Timepoint
In the first visit and then every four months
Method of measurement
The Beck Anxiety Inventory
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.