Effect of Plantago syrup on the prevention of acute radiation-induced mucositis in patients with head and neck cancer
Design
Randomized, double blind clinical trials with control group and parallel group design.
The sample size is 46.
Settings and conduct
This study i conducted in two center ( Isfahan hospitals and Kashan Yasrebi Hospital). The study was a randomized double-blind clinical trial. Patients are randomly (using the balance block method) divided into two groups: intervention and control.The patient and the examination physician are blinded. Drug and placebo are similar in shape, packaging, color, smell and taste.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with 17-65 years old in both sexes; candidate for radiotherapy for head & neck cancers; life expectancy over 1 year; Good performance status in ECOG questionnaire; at least 4 areas in radiation therapy (RT) fields. Non-inclusion criteria: Patients with organic & suppressive disorders; use of drugs effective on salivary glands, smoking or alcohol consuming; history of radiotherapy for mouth and oropharynx in the last 6 months.
Intervention groups
In intervention group: Plantago syrup; 7.5 cc after meal; three times per day for 7 weeks.
In control group: placebo syrup; 7.5 cc after meal; three times per day for 7 weeks.
Main outcome variables
Mucositis; pain; quality of life; side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190312043027N1
Registration date:2019-08-14, 1398/05/23
Registration timing:registered_while_recruiting
Last update:2019-08-14, 1398/05/23
Update count:0
Registration date
2019-08-14, 1398/05/23
Registrant information
Name
Gholamreza Mohammadsoltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3362 4281
Email address
rezamohammadsoltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-22, 1397/07/30
Expected recruitment end date
2019-08-20, 1398/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Plantago Major compared to placebo on prevention of radiation induced acute mucositis in head and neck cancer patients
Public title
The effects of Plantago Major on prevention of radiation induced acute mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for radiotherapy for head & neck cancer
Patients with 17-65 years old
Life expectancy over 1 year
Good performance status in Eastern Cooperative Oncology Group (ECOG) questionnaire
At least 4 areas in radiotherapy (RT) fields
Exclusion criteria:
Using alcohol
Use of drugs affecting salivary gland secretions,such as antidepressants, Opiates, anti-hypertensives, anti-histamines.
Use of mouthwash solutions
Smoking
History of mouth and oropharynx radiation therapy and chemotherapy in the last six months.
History of connective tissue diseases affecting salivary glands such as Sjugren syndrome , Rheumatoid arthritis and Lupus and immunodeficiency diseases
Grade 3-4 mucositis
Candidiasis, oral herpes
Hospitalization or need to Total Parental Nutrition ( TPN)
Dissatisfaction to continue participating in the study
Treatment failed
Diabetes
Age
From 17 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize individual blocks using random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug and placebo in the form of syrup and without mentioning the name of the drug in the pharmacy company Sanabel , affiliated to the Center for Clinical Trial Research of Traditional Medicine, Shahed University, was provided by a third person who did not participate in the rest of the study.
The investigator and team conducting research and evaluating outcomes, as well as participants, did not know the type of contents of syrup bottles.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Basij Square., Arak., Markazi Province.
City
Arak
Province
Markazi
Postal code
8715973454
Approval date
2018-06-19, 1397/03/29
Ethics committee reference number
IR.ARAKMU.REC.1397.059
Health conditions studied
1
Description of health condition studied
Radiation-induced mucositis in head and neck cancer
ICD-10 code
K12.3
ICD-10 code description
Oral mucositis (ulcerative)
Primary outcomes
1
Description
mucositis
Timepoint
Baseline of radiation therapy; every week after initiation of radiation therapy for 5 weeks and two weeks after intervention terminated.
Method of measurement
Examination of oral cavity
2
Description
Pain
Timepoint
At the baseline and every week from first to seventh.
Method of measurement
Visual analogue scale of pain
3
Description
Quality of life
Timepoint
At the baseline and every week from first to seventh.
Method of measurement
EORTC questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
Every week from first to seventh.
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Plantago syrup, three times per day,after each meal, each serving 7.5 cc, for 7 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo syrup, three times per day, after each meal, each serving 7.5 cc, for 7 weeks.