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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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History
# Registration date Revision Id
3 2020-04-18, 1399/01/30 130414
2 2019-10-02, 1398/07/10 107532
1 2018-12-02, 1397/09/11 69189
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  • General information

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    19
    No
    Yes
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    2
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    2018-12-18, 1397/09/27
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    2019-03-13, 1397/12/22
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    2019-03-27, 1398/01/07
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    Announcement of termination of patients recruitment
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    اعلام خاتمه بیمارگیری
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    each patients receives placebo for two weeks and then drug for two weeks (or conversely).
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    هر بیمار دو هفته دار و سپس دو هفته دارونما (یا بالعکس) دریافت کرد.

Protocol summary

Study aim
Determination the effect of spaghula husk mucilage on prevention of oral mucositis in breast cancer patients receiving adriamycin
Design
Double-blind randomized controlled clinical trial with placebo, with cross-over groups, sample size: 20 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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,
Intervention groups
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
Main outcome variables
Mucositis intensity, Intensity of pain, Quality of Life, Dry mouth

General information

Reason for update
Announcement of termination of patients recruitment
Acronym
IRCT registration information
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
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Fatemeh sadat Hasheminasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 8547
Email address
hashemifa67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
2018-12-18, 1397/09/27
Actual recruitment end date
2019-03-13, 1397/12/22
Trial completion date
2019-03-27, 1398/01/07
Scientific title
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
Public title
Effect of spaghula husk mucilage on prevention of chemotherapy-induced mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 17 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
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).
Randomization (investigator's opinion)
Randomized
Randomization description
use of random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman university of medical sciences
Street address
Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman
City
Kerman
Province
Kerman
Postal code
584-76175
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.KMU.REC.1397.239

Health conditions studied

1

Description of health condition studied
Adriamycin induced oral mucositis
ICD-10 code
K12.31
ICD-10 code description
Oral mucositis (ulcerative) due to antineoplastic therapy

Primary outcomes

1

Description
degree of oral mucositis according to WHO scale
Timepoint
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)
Method of measurement
WHO scale for oral mucositis

2

Description
degree of pain due to oral mucositis
Timepoint
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)
Method of measurement
Visual Analogue Scale

3

Description
quality of life
Timepoint
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)
Method of measurement
OHIP-14 questionnaire

4

Description
xerostomia
Timepoint
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)
Method of measurement
LENT-SOMA scale

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Teaching Hospital
Full name of responsible person
Seyed Mehdi Hashemi
Street address
Persian Gulf Expressway, Zahedan, Sistan and Baluchestan Province
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
0
Phone
+98 54 3329 5570
Email
avecina75483@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman university of medical sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman university of medical sciences, Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hasheminasab
Position
PhD student of Persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Persian Medicine, Amir Kabir crossroad
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
hashemifa67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Setayesh
Position
assistant proffesor of traditional Persian medicine
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Persian Medicine, Amir Kabir crossroad
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
msetayeshmail@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Hasheminasab
Position
PhD student of traditional Persian medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Persian Medicine, Amir Kabir crossroad
City
Kerman
Province
Kerman
Postal code
7618843883
Phone
+98 34 3211 0860
Email
hashemifa67@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
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
All data will be shared through a supplementary file after unidentified individuals.
When the data will become available and for how long
Start the access period from 6 months after printing results
To whom data/document is available
Researchers and other people can access data if they need it.
Under which criteria data/document could be used
For use in review articles, reprogramming and modeling can be used in other studies. In case of need, should be emailed to the programmer.
From where data/document is obtainable
Executor of plan or University
What processes are involved for a request to access data/document
Email the scheduler (Dr.Setayesh) ,he answers.
Comments
All information is available to others for the advancement of science.
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