Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with Hypozalix (artificial saliva) in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers
The goal of this randomized, single-center, phase II clinical trial study, is comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with Hypozalix (artificial saliva) in the radiation induced xerostomia and quality of life in patients with head and neck cancers. Inclusion criteria are: a minimum of 20 and maximum age of 70 years old; having xerostomia at least grade 1 based on clinical grading CTC; adverse event 4, and at least three months after the end of radiotherapy. Exclusion criteria: sudden changes in systemic conditions like that a patient requires extensive chemotherapy and surgical interventions, Failure / need parenteral nutrition (TPN) or hospitalization and unwillingness to continue participation in the study. Patients with a sample size of 60 persons in both two groups, enter the study. Intervention: Malva sylvestris and Alcea digitata formulation and Hypozalix (both three times daily) are given to patients for 4 weeks. Finally xerostomia and quality of life are measured by VAS scale, questionnaire and examination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012415860N1
Registration date:2014-01-24, 1392/11/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-24, 1392/11/04
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
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with Hypozalix (artificial saliva) in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers
Public title
Comparative evaluation of efficacy of the Malva sylvestris and Alcea digitata formulation with an artificial saliva in the radiation induced xerostomia and quality of life in patients with head– and– neck cancers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: xerostomia at least grade 1 based on clinical grading CTC; adverse event 4; age between 20 to 70 years old; physically and mentally able to fill out a questionnaire; willingness to participate in the study and informed consent; at least three months after the end of radiotherapy; not drinking alcohol; drugs affecting the salivary glands like antidepressant, opioids, antihypertensive, antihistamines, diuretics, all kind of mouthwash and artificial saliva; no history of connective tissue disease like Sjogren, rheumatoid arthritis, lupus, liver disease, kidney disease, major depression, diseases involving salivary glands, diabetes, chronic diseases such as diarrhea cause dehydration; the absence ofneutropenia, immunosuppression, myelosuppression
Exclusion criteria: sudden changes in systemic conditions like that a patient requires extensive chemotherapy and surgical interventions; failure/ need parenteral nutrition (TPN) or hospitalization; unwillingness to continue participation in the study.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Office of Research Affairs, Deputy of Research and Technology, Shahid Beheshti University of Medical
Street address
Sixth Floor, College Staff Building Number Two, Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Parvaneh St., Yemen St., Shahid Chamran Highway.
City
Tehran
Postal code
Approval date
2013-12-01, 1392/09/10
Ethics committee reference number
143
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 & weeks 2 and 4 after intervention
Method of measurement
VAS scale (determined by Question from patient) & Xerostomia Grade (determined by clinical examination)
2
Description
Quality of life
Timepoint
Before interventin and 4 weeks after intervention.
Method of measurement
EORTC questionnaire
Secondary outcomes
1
Description
Other Symptoms
Timepoint
Before interventin and 4 weeks after intervention.
Method of measurement
Question from patient
Intervention groups
1
Description
Intervention group 1: Hypozalix 100 mL artificial saliva sprays, three times a day, every time two puffs, for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Sachets of Malva sylvestris and Alcea digitata formulation, three times a day, each time one sachet into a cup of boiling water, stirred, and after cooling, drink it. For 4 weeks.
Category
Treatment - Drugs
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
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
Full name of responsible person
Rasool Choopani M.D, Ph.D, Assistant Professor
Street address
No.8 Shams Alley, opposite St tavanir, Vali Asr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
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
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Ghazaleh Heydarirad M.D
Position
Ph.D student of Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Sttree Tavanir, Vali Asr Street, Tehran
City
Tehran
Postal code
Phone
+98 218877352
Fax
Email
dr.ghazalrad@sbmu.ac.ir
Web page address
http://traditional.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Radiation Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Scien
Full name of responsible person
Ahmad Ameri M.D
Position
M.D, Board of specialists in Radiation - Oncology, Associate Professor
Other areas of specialty/work
Street address
Imam Hossein Hospital, Nezam Abad, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 7755 8081
Fax
Email
aham47@yahoo.com
Web page address
http://www.ehmc.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine Traditional Medicine and Materia Medica Research Center Shahid Behesh
Full name of responsible person
Ghazaleh Heydarirad
Position
ph.D student ofTraditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, Opposite Street Tavanir, Vali Asr Street
City
Tehran
Postal code
Phone
+98 21887735215
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)