Comparing the effectiveness of dexamethasone mouthwash compared to placebo on the prevention of mucositis caused by radiotherapy in patients with head and neck cancer
Design
A clinical trial with a control group, with parallel groups, 3 way-blind, randomized, phase two on 50 patients. For randomization with
Using the table of random numbers (by the site https://www.random.org) will be entered into one of the two investigated groups with 1:1 blocks
Settings and conduct
Study will be performed in the Radiotherapy Oncology Department of Namazi Hospital affiliated to Shiraz University of Medical Sciences. Patients suffering from head and neck cancers are randomly treated with dexamethasone mouthwash (dexamethasone with a concentration of 0.5 mg in 10 ml of normal saline) or placebo will be placed during radiotherapy treatment.Medicine and placebo (which are similar to the medicine in terms of shape, appearance, consistency and smell) will be placed in the same container and will be marked with code A and B. The patient, the attending physician, as well as the person who evaluates the side effects of the treatment will be blinded to the study group, and only a person outside the research team (pharmacologist who prepares the drugs) will be blinded to which drug group and the placebo group. will receive will be aware
Participants/Inclusion and exclusion criteria
Newly diagnosed patient
Having a pathological diagnosis of head and neck cancer
Presence of adjuvant or definitive radiotherapy indication
Intervention groups
Patients are treated with dexamethasone mouthwash (dexamethasone with a concentration of 0.5 mg in 10 ml of normal saline) or placebo (with the same daily dose) ) will receive
Main outcome variables
Preventing the occurrence of mucositis during radiotherapy treatment and helping to complete the treatment period without stopping the treatment and with less complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240525061893N1
Registration date:2024-07-21, 1403/04/31
Registration timing:retrospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Nooshin Dindar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4332
Email address
nooshindindar@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2024-10-29, 1403/08/08
Actual recruitment start date
2021-03-21, 1400/01/01
Actual recruitment end date
2024-03-02, 1402/12/12
Trial completion date
2024-03-02, 1402/12/12
Scientific title
Evaluation of dexamethasone solution efficacy on prevention of radiotherapy induced mucositis in patients with head and neck cancer
Public title
Evaluation of dexamethasone solution efficacy on prevention of radiotherapy induced mucositis in patients with head and neck cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Performance level of KPS≥70 (or ECOG score=0-1)
Newly diagnosed patient
Having a pathological diagnosis of head and neck cancer
Presence of adjuvant or definitive radiotherapy indication
The treatment dose is at least 60 Gry
Placement of at least half of the oral cavity in the radiotherapy treatment field
Exclusion criteria:
Lack of consent to participate in the study
Presence of chronic kidney (eGFR <50 ml/min), heart (EF <50%) and liver diseases (liver enzyme levels > three times normal)
History of previous malignancy
History of previous radiation therapy in the head and neck area
History of hypersensitivity reaction to dexamethasone mouthwash
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to one of the two study groups using a random number table (by https://www.random.org) with 1:1 blocks. It will be tried that the patients are the same in terms of age, performance status, tumor location, staging of the tumor, presence of underlying disease, total treatment dose, percentage of the oral cavity in the treatment field, dose of the oral cavity in the treatment field, and receiving chemotherapy
Blinding (investigator's opinion)
Double blinded
Blinding description
Medicine and placebo (which are similar to the medicine in terms of shape, appearance, consistency and smell) will be placed in the same container and will be marked with code A and B. The patient, the attending physician, as well as the person who evaluates the side effects of the treatment will be blinded to the study group, and only a person outside the research team (pharmacologist who prepares the drugs) will be blinded to which drug group and the placebo group. will receive will be aware
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of scholl of medicine -Shiraz University of Medical Sciences-medicine
Street address
No128, seda va sima Ave ,east ghodoosi Blvd
City
Shiraz
Province
Fars
Postal code
7184948336
Approval date
2022-12-25, 1401/10/04
Ethics committee reference number
IR.SUMS.MED.REC.1401.476
Health conditions studied
1
Description of health condition studied
Radiotherapy-induced mucositis in head and neck patients
ICD-10 code
K12.33
ICD-10 code description
Oral mucositis (ulcerative) due to radiation
Primary outcomes
1
Description
Treatment complications based on the checklist designed based on CTCAE v4.0 and the World Health Organization system
Timepoint
Weekly from the beginning of treatment until two months after treatment
Method of measurement
The basis of the checklist designed based on CTCAE v4.0 and the World Health Organization system
Secondary outcomes
empty
Intervention groups
1
Description
- Intervention group: Dexamethasone mouthwash (0.5 mg of dexamethasone in 10 ml of normal saline) - 10 cc of the solution is gargled in the mouth four times a day from the day before radiation therapy - until the end of the radiation. Treatment - the drugs are prepared in a sterile form by the pharmacist Dr. Maryam Kikhaei - training is provided orally and face-to-face to the patient and the patient's companion the day before the start of radiation therapy - and in case of any kind of problem or question of the patients, it is possible They will make a phone call or face to face
Category
Treatment - Drugs
2
Description
Control group: In this group, placebo patients with the same physical characteristics as those of the intervention group will be provided with a treatment that contains normal saline and with the same dosage and method of administration, and the training for the patients is also completely similar to intervention group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital, Shiraz
Full name of responsible person
Nooshin Dindar
Street address
No. 128, Motahari Square, Eastern Qudousi Blvd., Seda Va Sima St
City
Shiraz
Province
Fars
Postal code
7184948336
Phone
+98 71 3843 1765
Email
Nooshindindar@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamadhashem Hashempoor
Street address
No. 128, Motahari Square, Eastern Qudousi Blvd., Seda Va Sima St
City
Shiraz
Province
Fars
Postal code
7184948336
Phone
+98 71 3843 1765
Email
Nooshindindar@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Nooshin Dindar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zand St., Namazi Square, Namazi Medical Education Center
City
Shiraz
Province
Fars
Postal code
7184948336
Phone
00988431765
Fax
+98 71 3647 4326
Email
nooshindindar@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nooshin Dindar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zand St., Namazi Square, Namazi Medical Education Center
City
Shiraz
Province
Fars
Postal code
7184948336
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
nooshindindar@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nooshin Dindar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zand St., Namazi Square, Namazi Medical Education Center
City
Shiraz
Province
Fars
Postal code
7184948336
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
nooshindindar@ymail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as the information related to the main outcome, can be shared
When the data will become available and for how long
date relative to the time when summary data are published or otherwise made available (e.g., starting 6 months after publication
To whom data/document is available
available for people working in academic institutions and people working in businesses can also apply to receive it
Under which criteria data/document could be used
No other criteria
From where data/document is obtainable
Nooshindindar@ymail.com
What processes are involved for a request to access data/document