Protocol summary
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Study aim
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Determination the effect of spaghula husk mucilage on prevention of oral mucositis in breast cancer patients receiving adriamycin
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Design
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Double-blind randomized controlled clinical trial with placebo, with cross-over groups, sample size: 20 patients
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Settings and conduct
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breast cancer patients referring to Imam Ali Hospital Zahedan who are candidates for adriamycin and who have had mucositis in the first or second course of 4 courses of adriamycin, according to inclusion and exclusion criteria will enter the study. 20 patients will be enrolled in the study. Patients are randomly divided into two group of drug and placebo. both groups will be advised to adhere the oral hygiene instructions such as usage of soft toothbrush. At the start of the second or third course of adriamycin, the intervention will take place for 2 weeks, and after this two weeks, by the next dose of adriamycin.the place of the drug group will be replaced with the placebo group. In each intervention, relevant factors will be evaluated.
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Participants/Inclusion and exclusion criteria
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inclusion criteria: Breast cancer, Candidate for adriamycin, Age 17 to 65 years, Physical and mental ability to cooperate in filling in the questionnaire
exclusion criteria:
Use of alcohol, medicines affecting the salivary glands, mouthwashes and artificial saliva and cigarettes during the study; receiving prior radiotherapy in the oral and oropharynx; a history of connective tissue diseases, diseases that cause recurrent aphthous stomatitis ; third and fourth degree mucositis; Receiving drugs that affect oral mucositis, such as prostaglandin,
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Intervention groups
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Drug: spaghula husk 500 milligram+3 drop vinegar in 30 milliliter water 3 times a day
Placebo: (maltodextrin400mg+carbomer 80 mg+ Cinnamon20 mg) +3 drop triethanolamine in 30 ml water 3 times a day
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Main outcome variables
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Mucositis intensity,
Intensity of pain,
Quality of Life,
Dry mouth
General information
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Reason for update
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Announcement of termination of patients recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180923041093N1
Registration date:
2018-12-02, 1397/09/11
Registration timing:
prospective
Last update:
2020-04-20, 1399/02/01
Update count:
2
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Registration date
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2018-12-02, 1397/09/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-11, 1397/09/20
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Expected recruitment end date
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2019-03-11, 1397/12/20
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Actual recruitment start date
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2018-12-18, 1397/09/27
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Actual recruitment end date
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2019-03-13, 1397/12/22
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Trial completion date
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2019-03-27, 1398/01/07
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Scientific title
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Evaluation of the effect of Persian medicine based preparation from spaghula (Plantago Ovata Forsk) husk mucilage on prevention and treatment of oral mucositis in breast cancer patients receiving adriamycin
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Public title
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Effect of spaghula husk mucilage on prevention of chemotherapy-induced mucositis
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Breast cancer
Candidate for adriamycin
mucositis in screening course
Remaining two courses of adriamycin with two weeks interval
Age between 17 and 65 years
Life expectancy for more than a year based on physician or team estimates
Physical and mental ability to cooperate in filling in the questionnaire
The desire to participate in the study
Exclusion criteria:
Use alcohol
Use of drugs that affect salivary glands such as antipsychotics, opioids, antihypertensives, antihistamine, diuretics
Use of mouthwashes and artificial saliva and cigarettes
Receiving Early Radiation in mouth or oropharynx
The history of connective tissue diseases, such as Sjogren, rheumatoid arthritis, lupus
Liver and kidney disease
Major Depression
Diseases that affect salivary glands such as diabetes
Diseases that induce dehydration such as chronic diarrhea
Diseases of the immune system
Recurrent aphthous stomatitis
Receiving Lithium or Levothyroxine for interference with spaghula
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Age
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From 17 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
each patients receives placebo for two weeks and then drug for two weeks (or conversely).
Actual sample size reached:
19
More than 1 sample in each individual
Actual sample size in each individual:
2
each patients receives placebo for two weeks and then drug for two weeks (or conversely).
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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use of random numbers table
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The drug and placebo will coded by a third person (A - B). Therefore, the patient, researchers and outcome evaluators do not know which patient is in the drug group and which patient is in the placebo group. After the completion of the sampling, the third person will offer the codes to the data analyzer.
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-30, 1397/07/08
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Ethics committee reference number
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IR.KMU.REC.1397.239
Health conditions studied
1
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Description of health condition studied
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Adriamycin induced oral mucositis
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ICD-10 code
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K12.31
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ICD-10 code description
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Oral mucositis (ulcerative) due to antineoplastic therapy
Primary outcomes
1
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Description
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degree of oral mucositis according to WHO scale
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Timepoint
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Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention)
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Method of measurement
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WHO scale for oral mucositis
2
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Description
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degree of pain due to oral mucositis
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Timepoint
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Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention)
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Method of measurement
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Visual Analogue Scale
3
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Description
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quality of life
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Timepoint
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Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention)
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Method of measurement
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OHIP-14 questionnaire
4
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Description
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xerostomia
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Timepoint
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Precisely before the intervention, 7 days after the start of intervention and 14 days after the start of intervention (the last day of the intervention)
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Method of measurement
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LENT-SOMA scale
Intervention groups
1
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Description
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Intervention group: A mixture of (500 ml ispaghula husk and 3 drops of vinegar in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days. The intervention begins from the start of the Adriamycin Course and continues until the next course begins.
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Category
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Treatment - Drugs
2
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Description
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Control group: placebo: A mixture of (400 mg maltodextrin + 80 mg carbomer +20 mg cinnamon +3 drops of triethanolamine in 30 cc water) should be kept in the mouth for 1 minute then poured out, three times a day . For 14 days. The intervention begins from the start of the Adriamycin Course and continues until the next course begins.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kerman university of medical sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data will be shared through a supplementary file after unidentified individuals.
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When the data will become available and for how long
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Start the access period from 6 months after printing results
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To whom data/document is available
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Researchers and other people can access data if they need it.
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Under which criteria data/document could be used
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For use in review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer.
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From where data/document is obtainable
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Executor of plan or University
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What processes are involved for a request to access data/document
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Email the scheduler (Dr.Setayesh) ,he answers.
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Comments
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All information is available to others for the advancement of science.