The goal of this randomized clinical trial study, is assessment of efficacy of the Malva sylvestris & Alcea digitata & Plantago Psyllium compound on prevention of radiation induced xerostomia in head and neck cancer patients. Inclusion criteria are: head and neck cancer patients who candidate for radiation therapy, with a minimum of 17 and maximum age of 65 years old, having Good Performance status according with ECOG questionnaire criteria, having at least 4 regions of mucositis (based on a measure of mucositis) in the field of radiation therapy. Exclusion criteria: grade 3 & 4 mucositis, candidiasis and oral herpes infection, sudden changes in the patient's condition or disease in which changing the predicted radiation procedure for patient before getting to dose of 50 Gy, failure / need parenteral nutrition (TPN) or hospitalization and unwillingness to continue participation in the study. Patients with a sample size of 44 persons in both two groups, enter the study. Intervention: experimental group received the Malva sylvestris & Alcea digitata compound and "standard protocol of care", and the control group received placebo and "health care standard protocol". Duration of intervention is started at the beginning of the radiation therapy and continued till 2 weeks after finishing radiation therapy. Xerostomia and quality of life are measured by VAS scale, questionnaire and examination before intervention, 2 and 6 weeks after finishing radiation therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091015860N3
Registration date:2015-09-17, 1394/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-17, 1394/06/26
Registrant information
Name
Ghazaleh Heydarirad
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 6027
Email address
dr.ghazalrad@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-16, 1394/06/25
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced xerostomia in head and neck cancer patients
Public title
Efficacy of the Malva sylvestris & Alcea digitata &Plantago Psyllium on prevention of radiation induced xerostomia in head and neck cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include:
1. head and neck cancer patients who candidate for radiation therapy
2. minimum age of 17 and maximum age of 65 years old
3. having Good Performance status according with ECOG questionnaire criteria
4. having at least 4 regions of mucositis (based on a measure of mucositis) in the field of radiation therapy
5. physically and mentally able to fill out a questionnaire
6. willingness to participate in the study
7. survival more than one year according to the oncologist or treatment team.
Exclusion criteria:The use of alcohol, medicines which affecting the salivary glands such as: anti-depression, opioids, anti-hypertensive, antihistamines, diuretics, types of mouthwash and artificial saliva and smoking during the study; Receiving radiation therapy and chemotherapy in the mouth and oropharynx in the six months ago; The history of connective tissue diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, liver and kidney disease, major depression, diseases involving salivary glands, diabetes, chronic diseases such as diarrhea cause dehydration, immune suppression disorders, myelosuppression, disorders which causing frequent aphthous stomatitis; Sudden changes in the patient's condition or disease in which changing the predicted radiation procedure for patient before getting to dose of 50 Gy; Grade 3 & 4 mucositis; Candidiasis and oral herpes infection; Failure/ need parenteral nutrition (TPN) or hospitalization; Unwillingness to continue participation in the study
Age
From 17 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz boulevard, Tehran University of Medical Sciences, Tehran
City
Tehran
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
27838
Health conditions studied
1
Description of health condition studied
Radiation induced xerostomia
ICD-10 code
K11.7
ICD-10 code description
Dry mouth, unspecified
Primary outcomes
1
Description
Xerostomia
Timepoint
Before interventin and 2 and 6 weeks after finishing radiation therapy
Method of measurement
VAS scale (determined by Question from patient) & Xerostomia Grade (determined by clinical examination)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before interventin and 2 and 6 weeks after finishing radiation therapy
Method of measurement
EORTC questionnaire
Intervention groups
1
Description
In the exprimental group: Malva sylvestris & Alcea digitata & Plantago Psyllium compound and "health care standard protocol", starting at begining of radiation therapy and will continue up to 2 weeks after finishing radiation therapy, three times a day.
Category
Treatment - Drugs
2
Description
In the control group, placebo and "health care standard protocol", starting at begining of radiation therapy and will continue up to 2 weeks after finishing radiation therapy, three times a day.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Radiation Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Scien
Full name of responsible person
Ahmad Ameri,M.D, Board of specialists in Radiation - Oncology, Associate Professorl
Street address
Imam Hossein Hospital, Nezam Abad, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Rezaeizade
Street address
Faculty of Traditional Medicine, west. Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Heydarirad
Position
Phd of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, west. Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21229885512
Fax
Email
dr.ghazalrad@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Heydarirad
Position
Phd of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, west. Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21229885512
Fax
Email
dr.ghazalrad@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Heydarirad
Position
Phd of Iranian Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine, west. Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21229885512
Fax
Email
dr.ghazalrad@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)