The effect of mouthwash of hydroalcoholic extract of 15% of Iranian oak jaft (Quercus brantii) on prevention, pain intensity and extent of oral mucosa in cancer patients undergoing chemotherapy and radiotherapy, a randomized trial study
Determining the effect of Iranian oak hydroalcoholic extract mouthwash on the prevention and management of oral mucositis in cancer patients undergoing chemotherapy and radiotherapy in Shahrekord Parsian Hospital and clinics.
Design
In the present study, a sampling method was used based on the census of all cancer patients referred, hospitalized or outpatients to the chemotherapy and radiotherapy departments of Shahrekord Parsian Hospital and clinics that met the conditions for inclusion in the study. Then by randomly allocating drug and placebo to all patients who meet the conditions for entering the study, the subjects were studied.The 15% hydroalcoholic extract of Iranian oak was prepared at the Medicinal Plant Research Center of Shahrekord University of Medical Sciences, and 40 135 cc glass containers containing medicine and 40 containers containing placebo were prepared and sealed according to British Pharmacopoeia (BP) instructions.
Settings and conduct
The method of coding was such that the researcher was blind to the contents and codes on the containers.
Participants/Inclusion and exclusion criteria
Entry criteria
• Does not have any underlying immune system defects.
• Be free of any mucositis during study entry.
• Having informed and written consent from the patient or the patient's guardian to participate in the study
• Age above 15 years
• Definitive diagnosis of cancer by a specialist doctor
• Undergoing chemotherapy or radiotherapy, but patients have not received radiotherapy or chemotherapy in the last three months
Intervention groups
All patients with inclusion criteria
Main outcome variables
Occurrence of pain, intensity of pain, intensity of mucositis
General information
Reason for update
Acronym
MDCHR
IRCT registration information
IRCT registration number:IRCT20221028056322N1
Registration date:2022-11-28, 1401/09/07
Registration timing:retrospective
Last update:2022-11-28, 1401/09/07
Update count:0
Registration date
2022-11-28, 1401/09/07
Registrant information
Name
Jafar Moghadassi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5277
Email address
moghadasi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
2021-06-21, 1400/03/31
Actual recruitment end date
2022-01-20, 1400/10/30
Trial completion date
2022-02-03, 1400/11/14
Scientific title
The effect of mouthwash of hydroalcoholic extract of 15% of Iranian oak jaft (Quercus brantii) on prevention, pain intensity and extent of oral mucosa in cancer patients undergoing chemotherapy and radiotherapy, a randomized trial study
Public title
The effect of mouthwash of hydroalcoholic extract of Iranian oak jaft
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
does not have any underlying immune system defects.
Be free of any mucositis at the time of entering the study.
Having informed and written consent from the patient or the patient's guardian to participate in the study.
Age above 15 years
under chemotherapy or radiotherapy, but patients have not undergone radiotherapy or chemotherapy in the last three months.
Exclusion criteria:
Age below 15 years
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Actual sample size reached:
79
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, a sampling method was used based on the census of all cancer patients referred, hospitalized or outpatients to the chemotherapy and radiotherapy departments of Shahrekord Parsian Hospital and clinics that met the conditions for inclusion in the study. Then by randomly allocating drug and placebo to all patients who meet the conditions for entering the study, the subjects were studied.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The target population consisted of 80 people in the present study, who were selected from among cancer patients referred, hospitalized or outpatients in the chemotherapy and radiotherapy departments of Parsian Shahrekord Hospital and clinics, using the census-based sampling method. Then, the patients were studied by simple random assignment of drug and placebo to all patients who meet the conditions for entering the study. Identical containers containing drug and placebo were coded by the Medicinal Plants Study Center of Shahrekord University of Medical Sciences under the supervision of respected professors of medicinal plants and kept in the refrigerator until delivery to the patients. The method of coding has been such that the researcher of the contents and the included codes
Placebo
Used
Assignment
Parallel
Other design features
In this study, random allocation of drugs was done. If in parallel studies, random allocation of patients to two control and intervention groups was done.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahre kord university of Medical Sciences
Street address
Address: Shahrekord, Kashani Boulevard, University Headquarters, Building No. 2 Postal Code: 8815713471 Phone: 038-33342414 vcrt@skums.ac.ir
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2021-05-06, 1400/02/16
Ethics committee reference number
IR.SKUMS.REC.1400.17
Health conditions studied
1
Description of health condition studied
Oral mucositis caused by chemotherapy and radiotherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence rate, severity of pain and severity of oral mucositis
Timepoint
Before, one or two weeks after the intervention
Method of measurement
World Health Organization Mucositis Severity Measurement Tool and Pain Visual Analogue
Secondary outcomes
1
Description
Patient comfort level
Timepoint
Before, one or two weeks after the intervention
Method of measurement
Visual analogue of pain
Intervention groups
1
Description
Intervention group: In both intervention and control groups, drug or placebo was randomly assigned.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy department of Shahrekord Parsian Hospital and chemotherapy clinics of Dr. Amiri and Mas
Full name of responsible person
Dr. Jafar Moghdisi
Street address
Shahrekord, Kashani Boulevard, University Headquarters, Building No. 2 Postal Code: 8815713471
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 2907
Email
moghadasi@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raisi
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
Shahr e Kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
1
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammad Reza Kiani
Position
Master's student in internal surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati Street, Koche 22, Mehr Complex
City
SHahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3333 5277
Email
mohammadrezakianisalmi57@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Jafar Moghdisi
Position
Assistant Professor, Faculty of Nursing and Midwifery, Shahrkar University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
SHahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 2907
Email
moghadasi@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Jafar moghadasi
Position
Assistant Professor, Faculty of Nursing and Midwifery, Shahrekord University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord, Kashani Blvd., University Headquarters, Building No. 2
City
SHahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 2907
Email
moghadasi@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD