A clinical trial to assess the effectiveness of antiemetic and anti-halitosis topical peppermint cream and orally ingestible peppermint oxymel mouthwash in breast cancer patients during chemotherapy
Investigating the impact of topical peppermint cream and orally ingestible peppermint oxymel mouthwash on nausea and halitosis of breast cancer patients receiving chemotherapy
Design
A randomized one-blind phase د3 clinical trial on 225 patients, having control, and parallel groups. Randomization achieves by distinguishing participants into 6 blocks.
Settings and conduct
This study is to improve nausea and halitosis in patients with breast cancer. In addition to taking anti-nausea medications including Aprepitant and Dexamethasone, patients take two oral mouthwash drugs peppermint oxymel mouthwash and topical peppermint cream on days 1 to 6 of each course of chemotherapy. The research is carried out jointly in the trusted Motamed Cancer Institute and Emam Reza hospital. For data collection a questionnaire utilized, containing a tale in which patients rank their halitosis from 1-10; checking once per 2 weeks with the center. Furthermore, the vomiting and nausea questionnaire will be completed by the corresponding nurse. It is only possible to blind the researcher and analyst.
Participants/Inclusion and exclusion criteria
Stages 1 to 4 breast cancer patients that received chemotherapy.
Intervention groups
The control group receives anti-nausea drugs, one of the test groups receives ingestible peppermint oxymel mouthwash, and the other test group uses topical peppermint Cream in the form of topical on their forehead and behind ears, in addition to the control drugs.
Main outcome variables
Mouth halitosis; nausea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201219049763N1
Registration date:2021-06-08, 1400/03/18
Registration timing:prospective
Last update:2021-06-08, 1400/03/18
Update count:0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
Alireza Madjid Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 6208
Email address
majidansari@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-20, 1400/03/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to assess the effectiveness of antiemetic and anti-halitosis topical peppermint cream and orally ingestible peppermint oxymel mouthwash in breast cancer patients during chemotherapy
Public title
Assessing the effectiveness of topical peppermint cream and orally ingestible peppermint oxymel mouthwash on halitosis and vomiting of breast cancer patients during chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No history of nausea and vomiting for other reasons
Full consciousness
Literacy
Complete satisfaction in participating in this project
Breast cancer, ac4T4 chemotherapy regimen, taking anti-nausea and vomiting drugs Aprepitant and Dexamethasone
No history of allergies Medicinal plants
No history of respiratory diseases, asthma, diabetes and autoimmune diseases
Exclusion criteria:
Eliminate patients who use medications or treatments other than those prescribed during the study to reduce nausea and vomiting
Patients who forget to use the product and mouthwash three or more times in a row
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
225
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by assigning the subjects under study to 6 blocks. In each block, individuals are randomly assigned to one of the groups using topical peppermint, peppermint oral mouthwash, and control in a ratio of 2-2-2. The order of random assignment of individuals to the study groups in each block is kept in sealed envelopes, and the individual who has nothing to do with measuring the outcomes is responsible for assigning individuals to different treatments.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the difference in the combination of the two drugs used, it is not possible to blind the participant and clinical care. Also, in order to follow the patients and evaluate the effectiveness and side effects of the drug, it is necessary to emphasize the adherence to the drug, so the evaluator cannot be blind. In this case, it is only possible to blind the researcher and analyst.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Motamed Cancer Institute
Street address
Gandhi South
City
Tehran
Province
Tehran
Postal code
1517964311
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.ACECR.IBCRC.REC.1399.017
Health conditions studied
1
Description of health condition studied
Breast cancer patients treated with chemotherapy drugs
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Nausea score in questionnaires
Timepoint
At the beginning of the study, every day based on the Daily questionnaire, every 14 days based on the Rhodes questionnaire
Method of measurement
Daily questionnaire and Rhodes questionnaire
2
Description
Halitosis scores on questionnaires
Timepoint
At the beginning of the study, every day based on the Daily questionnaire, every 14 days based on the Rhodes questionnaire
Method of measurement
Daily questionnaire and Rhodes questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: In addition to taking the anti-nausea and antiemetic drugs Aprepitant and Dexamethasone, patients use mint serpentine mouthwash.Its ingredients are 5% water, 5% honey and 1% grape vinegar, to which 2% peppermint extract is added. How to use: 3 times a day, on days 1 to 6 of each course of chemotherapy. Each time, 2 tablespoons (equivalent to 10 ml) of mouthwash mixed with 6 tablespoons of water are mixed in the mouth and then swallowed.
Category
Treatment - Drugs
2
Description
Patients use topical peppermint cream in addition to the anti-nausea and antiemetic drugs Aprepitant and Dexamethasone.The ratio of its components is Cetostearyl alcohol 8g, Cetomacrogol 2g, poly ethylen glycol 6g , propylen glycol 6g, ethanol 10g, distilled water 60cc, peppermint essential oil 1cc. How to use: 3 times a day, on days 1 to 6 of each course of chemotherapy. Each time, rub 1 cm on the forehead and 0.5 cm on the back of each ear.
Category
Treatment - Drugs
3
Description
Control group: Patients taking only the usual anti-nausea and vomiting medications Aprepitant and Dexamethasone.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motamed Cancer Institute
Full name of responsible person
Ramin Sarami Froshani
Street address
No.146, South Gandhi Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6308
Email
icbc@acecr.ac.ir
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Mohsen Rajae Nejad
Street address
West Fatemi Street, North Shahid Etemadzadeh Street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
icbc@acecr.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Ramin Sarami froshani
Street address
No.146, South Gandhi Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6208
Email
icbc@acecr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Alireza Madjid Ansari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Integrative Oncology
Street address
No. 146 , South Gandhi Ave , Gandhi Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6208
Fax
Email
majidansari@acecr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Alireza Madjid Ansari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Integrative Oncology
Street address
No. 146 , South Gandhi Ave , Gandhi Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6208
Fax
Email
majidansari@acecr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Reyhane Ghadirian
Position
Expert
Latest degree
Master
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No.146, South Gandhi Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 6208
Email
reyhane_ghadirian@yahoo.com
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