Determining The Effect of Citrus Medica Paste (CMP) on CINV In Breast Cancer (BC)
Design
A clinical trial with a control group, community-based and functional, with factorial groups, without blinding, randomized (140 people)
Settings and conduct
Proposal Is an RCT Study, that was Conducted On Women with NV due to BC Who Were Referred to The Chemotherapy Department of Imam Khomeini Hospital Affiliated with TUMS (2024)
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women Aged >18 with BC ؛Diagnosis of BC(Opinion of Hemato-Oncologist)؛History of Receiving at Least One Chemotherapy ؛History of Experiencing Nausea or Vomiting (NV) Following Chemotherapy ؛Not Receiving Anti-Nausea and Vomiting Medication in The Last 24 h؛Not Having a History of NV Due to Reasons Other Than Chemotherapy ؛No Hepatitis, Gastrointestinal Obstruction, Brain Malignancies or Brain Metastases؛Absence of Allergy to Citron //Exclusion Criteria: Suffering from Other Malignancies ؛Using Treatment Methods to Reduce Nausea Other Than the Usual Prescribed Anti-Nausea and Vomiting Drugs ؛Allergy to Citrus ؛Patients Undergoing Concurrent Radiotherapy ؛Unwillingness to Continue Participating in The Study؛Consumption of Citrus During the Last Week؛In Case of Forgetting to Use It Three Times
Intervention groups
In The Control and Intervention Groups, They Are Treated with AC Regimen. To Control the Nausea of Patients, On The Day of Chemotherapy, Dexamethasone at A Dose of 8 Mg and Kytril At A Dose of 3 Mg, And Aprepitant at A Dose of 80-125 Mg On the First and Second Days After Chemotherapy, and Olanzapine at 5 Mg Per Day It Is Given First and The Day After Chemotherapy. Only The Intervention Group Will Be Given One Tablespoon (10 gr) Of CMP Half an Hour Before Breakfast and Dinner for Five Days.
Main outcome variables
CINV; CMP dose; Age; Severity of nausea based on the INVR & VAS questionnaires
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240511061734N1
Registration date:2024-05-23, 1403/03/03
Registration timing:registered_while_recruiting
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Seyed peyman Khamechi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4535
Email address
khamechi-p@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Citrus Medicine Paste on Acute Nausea and Vomiting Caused by Chemotherapy in Breast Cancer Patients
Public title
The Effect of Citrus Medicine Paste on Nausea Caused by Chemotherapy in Breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women Aged 18 Years And Older Who Have Breast Cancer
Definitive Diagnosis Of Breast Cancer With The Opinion Of Hemato-Oncologist And Pathologist
History Of Receiving At Least One Course Of Chemotherapy Due To Breast Cancer
History Of Experiencing Nausea Or Vomiting Following Chemotherapy Sessions
Not Receiving Anti-Nausea And Vomiting Medicine In The Last 24 Hours
Not Having A History Of Nausea And Vomiting Due To Reasons Other Than Chemotherapy (Such As High Blood Pressure, Kidney Failure, Liver And Digestive Problems Causing Nausea)
Absence Of Hepatitis, Gastrointestinal Obstruction, Brain Malignancies Or Brain Metastases
Absence Of Allergy To Citron
Exclusion criteria:
Age
From 18 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients Will Be Divided Into Two Intervention And Control Groups By Random Blocks Of 4
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine. Tehran University of Medical Sciences
Street address
Palestine Square, Tous St., End of Tabriz Alley, Intersection of North Sarparast St., Faculty of Persian Medicine, Tehran University of Medical Sciences, plaque 27
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-09-13, 1402/06/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.341
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
2
Description of health condition studied
female breast cancer
ICD-10 code
C50.1
ICD-10 code description
Malignant neoplasm of central portion of breast
3
Description of health condition studied
breast cancer
ICD-10 code
D05.1
ICD-10 code description
Intraductal carcinoma in situ of breast
4
Description of health condition studied
citrus medica
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
CINV score in INVR questionnaire
Timepoint
Each Patient Is Evaluated Six Times (One Hour Before Chemotherapy, 12 Hours After Chemotherapy and On the Second, Third, Fourth and Fifth Days After Chemotherapy).
Method of measurement
INVR questionnaire
2
Description
CINV score in VAS questionnaire
Timepoint
Each Patient Is Evaluated Six Times (One Hour Before Chemotherapy, 12 Hours After Chemotherapy and On the Second, Third, Fourth and Fifth Days After Chemotherapy).
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People Suffering from Nausea and Vomiting Caused by Breast Cancer Chemotherapy, Who Receive One Tablespoon (10 Grams) Of Citrus Medica Paste Half an Hour Before Breakfast and Dinner for Five Days, In Addition to Routine Anti-Nausea Drugs.
Category
Treatment - Drugs
2
Description
Control group: Women with breast cancer are treated with ac regimen (chemotherapy). Adriamycin at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 are given every 2 weeks for 4 cycles. In addition to Adriamycin and cyclophosphamide to control nausea in patients on the day of chemotherapy, dexamethasone with a dose of 8 mg and kytril (granisetron) with a dose of 3 mg and aprepitant with a dose of 80-125 mg on the first and second days after chemotherapy and pills Olanzapine 5 mg is given on the first day and the day after chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Seyed Hasan Inanlu
Street address
The end of Keshavarz Boulevard, The intersection of Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2631
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Sari
Street address
Keshavarz Blvd., corner of Qods St., headquarters of Tehran University of Medical Sciences, 6th floor, room 605, affairs management unit
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8163 3619
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Peyman Khamechi
Position
Phd Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Palestine Square, Tous St., End of Tabriz Alley, Intersection of North Sarparast St., Faculty of Persian Medicine, Tehran University of Medical Sciences, plaque 27
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8897 4535
Email
khamechi-p@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Peyman Khamechi
Position
Phd Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Palestine Square, Tous St., End of Tabriz Alley, Intersection of North Sarparast St., Faculty of Persian Medicine, Tehran University of Medical Sciences, plaque 27
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8897 4535
Email
khamechi-p@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Peyman Khamechi
Position
Phd Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Palestine Square, Tous St., End of Tabriz Alley, Intersection of North Sarparast St., Faculty of Persian Medicine, Tehran University of Medical Sciences, plaque 27
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8897 4535
Email
khamechi-p@razi.tums.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