Effect of increase in duration of Aprepitant consumption from 3 to 6 days on the prevention of nausea and vomiting in women receiving combination of Anthracycline/Cyclophosphamide chemotherapy: A randomized, crossover, clinical trial
1) Objective: Better control of chemotherapy induced nausea and vomiting by increasing the duration of Aprepitant consumption in women with breast cancer who receive AC (Anthracycline/Cyclophosphatase) regimen chemotherapy.
2) Design: Randomized, crossover, controlled clinical trial, designed to evaluate the effect of increase in duration of Aprepitant usage from 3 days to 6 days on prevention of nausea and vomiting in women receiving combination of Anthracycline/Cyclophosphatase chemotherapy.
3) Setting and conduct: This trial is conducted in cancer referral university hos¬pital in Isfahan (Iran’s third largest city, located in the center of Iran), Iran
4) Participant including major eligibility criteria: patients who are under 50 years of age, diagnosed with breast cancer and scheduled to receive 4 courses AC regimens are included in the study. The following general exclusion criteria are considered: gastritis; diabetes and brain tumor.
5) Intervention: Fifty patients with breast cancer will enroll in this study through convenience sampling method. They will randomize into two groups. According to the design of the study, group 1 will receive treatment A (3 days regimen) in the first course of chemotherapy and treatment B (6 days regimen) in the second course; group 2 will receive treatment B follow by treatment A.
6) Main outcome measures criteria: Main outcome is complete response (CR) that is defined as no nausea and no episode of vomiting during the study period. For nausea and vomiting assessment, we used Eastern Cooperative Oncology Group (ECOG) COMMON TOXICITY CRITERIA questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040121574N1
Registration date:2015-06-20, 1394/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-20, 1394/03/30
Registrant information
Name
Negah Chabi Ahvazi
Name of organization / entity
Esfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 31 4521 3496
Email address
dr.n.ahvazi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of increase in duration of Aprepitant consumption from 3 to 6 days on the prevention of nausea and vomiting in women receiving combination of Anthracycline/Cyclophosphamide chemotherapy: A randomized, crossover, clinical trial
Public title
Investigation of the effect of increasing days of abitant capsul use in control of chemotherapy induced nausea and vomiting with AC regimen in women with breast cancer
Purpose
Prevention
Inclusion/Exclusion criteria
General inclusion criteria: Less than 50 years of age, diagnosed with breast cancer and scheduled to receive 4 courses Anthracycline/Cyclophosphamide (AC) regimens.
General exclusion criteria: previous history of gastritis, diabetes and brain tumor.
Age
From 24 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Efahan university of medical sciences
Street address
Isfahan university of medical sciences,Hezar Jerib street, Esfahan
City
Esfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
393449
Health conditions studied
1
Description of health condition studied
Chemotherapy induced nausia and vomitting
ICD-10 code
T45.1
ICD-10 code description
Antineoplastic and immunosuppressive drugs, Poisoning by primarily systemic and haematological agents, not elsewhere classifiedAntineoplastic and immunosuppressive drugs
2
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Complete response
Timepoint
6 days after begining of intervention
Method of measurement
Questionnaire based on ECOG criteria
Secondary outcomes
empty
Intervention groups
1
Description
6 days consumption of Abitant capsul
Category
Treatment - Drugs
2
Description
3 days consumption of Abitant capsul
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada Hosspital
Full name of responsible person
Dr.Simin Hemmati
Street address
Seyedoshohada Hosspital, Khayam street, Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan university of medical science
Full name of responsible person
Dr.Simin Hemmati
Street address
Isfahan university of medical sciences,Hezar Jerib street, Esfahan
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Esfahan university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan university of medical science
Full name of responsible person
Dr.Simin Hemmati
Position
Assistant professor
Other areas of specialty/work
Street address
Radiotherapy unit, Isfahan university of medical sciences,Hezar Jerib street, Esfahan
City
Esfahan
Postal code
Phone
+98 31 3793 2335
Fax
Email
hemati@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan university of medical science
Full name of responsible person
Dr.Simin Hemmati
Position
Assistant professor
Other areas of specialty/work
Street address
Radiotherapy unit, Isfahan university of medical sciences,Hezar Jerib street, Esfahan
City
Esfahan
Postal code
Phone
+98 31 3793 2335
Fax
Email
hamati@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan university of medical science
Full name of responsible person
Dr.Simin Hemmati
Position
Assistant professor
Other areas of specialty/work
Street address
Radiotherapy unit, Isfahan university of medical sciences,Hezar Jerib street, Esfahan
City
Esfahan
Postal code
Phone
00
Fax
Email
hemati@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)