Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial
Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial.
Design
Phase III randomized, double-blind, placebo-controlled clinical trial will be conducted on 70 patients, using block randomization method to randomize the experiment.
Settings and conduct
Study site: Shahid Rajaei Educational and Medical center
The mouthwash bottles will be numbered according to the randomized list and by a person who was not involved in patient registry and examination of oral mucositis; all involved in patient registry and examination of oral mucositis will not be informed about the numbers related to drug or placebo during the study.
Participants/Inclusion and exclusion criteria
Entry requirements:
Age 18 and above.
A patient with malignant solid tumor and candidate for chemotherapy (receiving medications with potential of almost similar mucositis: Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Gemcitabine, Dacarbazine, and Cisplatin).
Karnofsky status greater than or equal to 60%.
Oral and written satisfaction (consent) of patients to participate in survey.
No entry requirements:
Inability in using the mouthwash.
Smoking.
Increasing hypersensitivity to melatonin or any other components used in formulation.
History of head and neck radiotherapy.
Having any lesions inside the mouth.
Intervention groups
Patients within intervention group will receive 4 ml of 0.3% melatonin mouthwash three times a day, and the patients of the control group will use 4 ml of placebo mouthwash (without active ingredient of melatonin in the formulation) made in Alborz School of Pharmacy three times a day. The mouthwash will be used from the first day of chemotherapy, for 6 weeks.
Main outcome variables
Intensity of mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220213054015N1
Registration date:2022-04-12, 1401/01/23
Registration timing:prospective
Last update:2022-04-12, 1401/01/23
Update count:0
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
Aida Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3382 6525
Email address
abdiaida00@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis, a randomized double blinded placebo controlled clinical trial
Public title
Investigation of the effect of Melatonin mouthwash on prevention of chemotherapy-induced oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above.
A patient with malignant solid tumor and candidate for chemotherapy (receiving medications with potential of almost similar mucositis: Cyclophosphamide, Doxorubicin, Fluorouracil, Methotrexate, Gemcitabine, Dacarbazine, and Cisplatin).
Karnofsky status ≥ ۶۰%.
Oral and written satisfaction (consent) of patients to participate in survey.
Exclusion criteria:
Inability in using the mouthwash.
Smoking.
Increasing hypersensitivity to melatonin or any other components used in formulation.
History of head and neck radiotherapy.
Having any lesions inside the mouth.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly classified in two classes of melatonin and placebo using block randomization method (block of size 6), to randomize the experiment. The randomization sequence using a computer-based randomized list will be determined by a person not involved in patient registry, then the mouthwash bottles will be numbered according to the randomized list and by a person who was not involved in patient registry and examination of oral mucositis; anyone involved in patient registry and examination of oral mucositis will not be informed about the numbers related to drug or placebo during the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blinded clinical trial, which means the patient and the researcher who provide the drug or placebo to the patients and evaluate the patients, are not aware whether the mouthwash is a drug or placebo.for this purpose, after making melatonin mouthwash and placebo which will both be exactly the same in appearance, these mouthwashes are poured into totally the same bottles by a researcher who is not involved in patient recruitment and examination of oral mucositis; then they are numbered in blocks of 6 size on a list of random computer numbers. it is worth noting that this list and that each number belongs to drug or placebo, is only available to the senior researcher (supervisor) who is not involved in the patient recruitment and examination of oral mucositis.Then, these completely similar bottles, on which only one number is installed, are given to the student (person responsible for patient recruitment) so that the student can provide the bottles to the patients in the order of the number of patients who entering the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Safareyan St., Golshahr Ave.
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.ABZUMS.REC.1400.311
Health conditions studied
1
Description of health condition studied
chemotherapy-induced oral mucositis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of mucositis
Timepoint
At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash
Method of measurement
World Health Organization Toxicity Scale
Secondary outcomes
1
Description
Intensity of pain
Timepoint
At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash.
Method of measurement
Visual analog scale
2
Description
Quality of Life
Timepoint
At the beginning of the study (before initiating intervention), as well as, 7, 14, 21, 28, 35, and 42 days after using the melatonin mouthwash
Method of measurement
EORTC Quality of Life Questionnaire QLQ-C30
Intervention groups
1
Description
Intervention group:Patients will gargle 4 ml of melatonin mouthwash made in Alborz School of Pharmacy, three times a day (a measuring cup with defined volume will be provided to facilitate the use). The patients will be asked to keep the mouth wash in their mouth for a minute or as long as possible, before spitting out. The patients will be asked to avoid eating for the next 30 min after using the mouthwash. The mouthwash will be will be utilized from the first day of chemotherapy and will continue for the next 6 weeks. The purpose and advantages of this survey will be thoroughly explained to the patients to ensure the consistent use of mouthwash through the survey; patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone calls or social media. It should be noted that some errors might inevitably emerge during the survey.
Category
Prevention
2
Description
Control group:Patients will gargle 4 ml of placebo mouthwash made in Alborz School of Pharmacy (without melatonin active ingredient in mouthwash formulation) three times a day (a measuring cup with defined volume will be provided to facilitate the use). The patients will be asked to keep the mouth wash in their mouth for a minute or as long as possible, before spitting out. The patients will be asked to avoid eating for the next 30 min after using the mouthwash. The mouthwash will be will be utilized from the first day of chemotherapy and will continue for the next 6 weeks. The purpose and advantages of this survey will be thoroughly explained to the patients to ensure the consistent use of mouthwash through the survey; patients will also be inquired to join the survey in case of possible consistent accompaniment and complete consent. The practice of mouthwash by the patients will regularly be monitored via telephone calls or social media. It should be noted that some errors might inevitably emerge during the survey.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Educational and Medical Center
Full name of responsible person
Aida Abdi
Street address
Shahid Rajaei St.,Hesarak.
City
Karaj
Province
Alborz
Postal code
3197635141
Phone
+98 26 3457 0030
Email
Rajaei@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Deputy of research and technology
Street address
Safareyan St., Glshahr Ave.
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
Research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Elliyeh Ghadrdan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy,Next to Bahonar Hospital, Vali-ye-Asr St.,Shura Blvd., Azimieh, Karaj,Alborz Provice
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
Email
EL.ghardan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Elliyeh Ghadrdan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy,Next to Bahonar Hospital, Vali-ye-Asr St.,Shura Blvd., Azimieh, Karaj,Alborz Provice
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 26 3256 7175
Fax
Email
EL.ghardan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Aida Abdi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy,Next to Bahonar Hospital, Vali-ye-Asr St.,Shura Blvd., Azimieh, Karaj,Alborz Provice
City
Karaj
Province
Alborz
Postal code
3154686689
Phone
+98 21 3382 6525
Fax
Email
abdiaida00@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected data.
When the data will become available and for how long
After the end of the study and its publication.
To whom data/document is available
Researchers.
Under which criteria data/document could be used
Use for review studies.
From where data/document is obtainable
Corresponding author email.
What processes are involved for a request to access data/document