Determining the effect of Achillea wilhelmsii oral rinse on chemoradiotherapy induced oral mucositis in head and neck cancer patients
Design
Randomized controlled clinical trial with parallel groups, double blinded, phase 3 study on 36 patients. Randomization by using random number table.
Settings and conduct
According to the inclusion and exclusion criteria, 36 patients referring to the radiotherapy ward of Mehraneh specialized clinic of Zanjan will be selected to participate in the study and will be divided into two groups of intervention and control randomly. From the first day of cancer treatment, the intervention group will use Achillea wilhelmsii mouthwash and the control group will use placebo. Patients in both groups should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. All the patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale).
It should be noted that immediately after occurrence of grade 1 mucositis, in addition to using prescribed mouthwashes, patients in both groups will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1: Patients with head and neck malignancies
Exclusion criteria:
1: Patients with oral mucositis
2: Patients with any systemic diseases other than head and neck malignancies
3: Patients with a history of allergy to Achillea wilhelmsii and medicinal plants
4: Patients with a history of chemotherapy or radiotherapy
Intervention groups
The intervention will be consisted of Achillea wilhelmsii mouthwash in the study group and placebo mouthwash in the control group.
Main outcome variables
Onset time of oral mucositis; severity of oral mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180516039682N3
Registration date:2020-12-30, 1399/10/10
Registration timing:prospective
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Raheleh Akhavan rasoolzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8101
Email address
r.rasoolzadeh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Achillea wilhelmsii oral rinse on chemoradiotherapy induced oral mucositis in head and neck cancer patients
Public title
Effect of Achillea wilhelmsii oral rinse on chemoradiotherapy induced oral mucositis in head and neck cancers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with full consciousness
Patients older than 18 years and younger than 60 years
Patients with head and neck malignancies
Patients undergoing chemotherapy and radiotherapy
Exclusion criteria:
Patients with oral mucositis
Patients with any systemic diseases other than head and neck malignancies
Patients with a history of allergy to Achillea wilhelmsii and medicinal plants
Patients with a history of chemotherapy or radiotherapy
Patients with xerostomia
Use of drugs that reduce salivation
Use of antibiotics, antifungals and systemic anti-inflammatory drugs
Patients with malnutrition
Smoking and alcohol consumption
Use of dentures
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization: A person other than the investigator will blindly and randomly select a number from the random number table for each patient (by moving in all four directions up, down, left and right). If the selected number is even, the patient will assign to the control group and if the selected number is odd, the patient will assign to the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, Achillea wilhelmsii mouthwash and normal saline mouthwash (placebo) will be available to patients in bottles of the same shape, size and dark color. Participants , outcome assessor and data analyzer will be blinded to the type of mouthwash and the patient's group. In this study, the pharmacist, as the person responsible for preparing mouthwash, will not be blinded to the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Central Station of Zanjan University of Medical Sciences, The Beginning of the Islamic Republic Boulevard, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-09-01, 1399/06/11
Ethics committee reference number
IR.ZUMS.REC.1399.216
Health conditions studied
1
Description of health condition studied
Oral mucositis (Stomatitis)
ICD-10 code
K12
ICD-10 code description
Stomatitis and related lesions
Primary outcomes
1
Description
Onset time of oral mucositis
Timepoint
Days 0, 7, 14, 21 and 28 after starting cancer treatment
Method of measurement
Clinical examination by a dentist based on World Health Organization oral mucositis grading scale.
2
Description
Severity of oral mucositis
Timepoint
Days 0, 7, 14, 21 and 28 after starting cancer treatment
Method of measurement
Clinical examination by a dentist based on World Health Organization oral mucositis grading scale.
Secondary outcomes
1
Description
Patient's weight
Timepoint
Days 0, 7, 14, 21 and 28 after starting cancer treatment
Method of measurement
Using a digital scale
2
Description
Severity of oral pain
Timepoint
Days 0, 7, 14, 21 and 28 after starting cancer treatment
Method of measurement
Questionnaire
3
Description
Satisfaction with mouthwash
Timepoint
Days 0, 7, 14, 21 and 28 after starting cancer treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: From the first day of cancer treatment, the intervention group will use Achillea wilhelmsii mouthwash. Achillea wilhelmsii mouthwash will be prepared in the pharmacognosy laboratory of the Faculty of Pharmacy of Zanjan University of Medical Sciences. Patients should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. Patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale). Immediately after occurrence of grade 1 mucositis, in addition to using Achillea wilhelmsii mouthwash, patients will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment.
Category
Treatment - Drugs
2
Description
Control group: From the first day of cancer treatment, the control group will use placebo mouthwash. Normal saline solution produced by Shahid Ghazi Pharmaceutical Company of Tabriz will be used as a placebo. Patients should hold 15 ml of the prescribed mouthwash in their mouth for 3 minutes 4 times a day (after each meal and before bed) and then expel it. Patients will undergo oral examination on days 0, 7, 14, 21, and 28 to evaluate the severity of the mucositis (according to World Health Organization scale). Immediately after occurrence of grade 1 mucositis, in addition to using placebo mouthwash, patients will use Magic mouthwash, which is a common treatment for oral mucositis due to cancer treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehraneh Radiotherapy Clinic of Zanjan
Full name of responsible person
Dr. Maryam Vasheghani
Street address
Mehraneh Radiotherapy Clinic, Mehraneh Blvd., Prof. Sobouti Blvd., Gavazang Rd.
City
Zanjan
Province
Zanjan
Postal code
4515743551
Phone
+98 24 3304 4101
Fax
+98 24 3141 1300
Email
mehraneh.markazi@gmail.com
Web page address
https://www.mehranehcharity.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Central Station of Zanjan University of Medical Sciences, The Beginning of the Islamic Republic Boulevard, Azadi Square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Email
Pr@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Raheleh Akhavan Rasoolzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Zanjan university of medical sciences, 13th Ave., Mahdavi Blvd., Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8101
Fax
Email
R.rasoolzadeh@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Raheleh Akhavan Rasoolzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Zanjan university of medical sciences, 13th Ave., Mahdavi Blvd., Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8101
Fax
Email
R.rasoolzadeh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Raheleh Akhavan Rasoolzadeh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Zanjan university of medical sciences, 13th Ave., Mahdavi Blvd., Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8101
Fax
Email
R.rasoolzadeh@zums.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