Evaluation of Bene mouthwash for prevention of chemotherapy-induced oral mucositis
Design
A placebo-controlled parallel-group triple-blind randomized clinical trial
Settings and conduct
The clinical trial will be conducted at the Firoozgar Hospital, and eligible patients admitting to the blood ward for chemotherapy will be recruited. Pre-coded randomized placebo and drug mouthwashes will be delivered to the subjects. The severity of oral mucositis will be assessed using the World Health Organization grading system and a questionnaire at baseline and on days 21, 14, 7, 3 after the intervention. Patients, healthcare providers, and the data analyzer will all be blind in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) age 18 to75 years
2) isn't first cycle of chemotherapy
3)receipt of at least two cytotoxic drugs
4)a treatment regimen containing 5-fluorouracil
5) history of mucositis or any oral complications due to chemotherapy
6) absence of mucositis at recruitment
7) performance status grade of less than or equal to two according to the Eastern Cooperative Oncology Group (ECOG) scale.
Exclusion criteria:
1) simultaneous radiotherapy in head and neck
2) pregnancy and lactation
3) allergic reaction.
Intervention groups
Two parallel groups; one receives Bene mouthwash while the other is given the placebo
Main outcome variables
Severity of the oral mucositis based on the World Health Organization grading system; soreness or pain in the mouth; trouble with talking and swallowing; blood and feeling of dryness in the mouth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191023045223N1
Registration date:2020-07-29, 1399/05/08
Registration timing:registered_while_recruiting
Last update:2020-07-29, 1399/05/08
Update count:0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Atefe Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7687 1250
Email address
a.fathi2696@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Bene (Pistacia atlantica) oleoresin mouthwash for prevention of chemotherapy-induced oral mucositis
Public title
Bene mouthwash for prevention of chemotherapy-induced oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
isn't first course chemotherapy
Receipt of at least two cytotoxic drugs;
a treatment tment regimen containing 5-fluorouracil (5fu);
history of mucositis, dryness, or any oral complications in the previous courses of chemotherapy;
absence of oral mucositis at the beginning of the study;
performance status grade of less than or equal to two according to the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion criteria:
Simultaneous radiotherapy in head and neck;
sensitivity to the Pistacia atlantica;
pregnancy and lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The blockchain randomization is employed and random number table is used as the randomization tool.
Blinding (investigator's opinion)
Triple blinded
Blinding description
A person not involved in the study will code the mouthwashes and the coded mouthwashes will be given to the patients. The participants, the researcher, the data analyst, and the healthcare providers involving the physician and the nurses will not be aware of the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethis committee of Islamic Azad University of Tehran Medical Sciences
Street address
Yakhchal st., Gholhak st., Dr. Shariati st.
City
tehran
Province
Tehran
Postal code
1941933111
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.IAU.TMU.REC.1398.110
Health conditions studied
1
Description of health condition studied
oral mucositis
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy
Primary outcomes
1
Description
The severity of the oral mucositis according to the World Health Organization grading system
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
The World Health Organization Grading System
2
Description
Soreness or pain in the mouth
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
3
Description
Trouble with talking
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
4
Description
Trouble with eating solid foods (such as bread)
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
5
Description
Trouble with eating soft foods (such as yogurt and baked potatoes)
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
6
Description
Difficulty in swallowing due to the sore throat
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
7
Description
Taste changes
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
8
Description
Bleeding or sore gums
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
Secondary outcomes
1
Description
Feeling of dryness in the mouth
Timepoint
Baseline and 3, 7, 14, 21 days after the intervention
Method of measurement
Patient-reported outcomes based on scoring 0 to 10
Intervention groups
1
Description
Intervention group: receiving Bene oleoresin 1% mouthwash to be used twice daily for a week
Category
Prevention
2
Description
Control group: receiving placebo (absence of Bene oleoresin) to be applied twice daily for a week