]>
IRCT2015091015860N3 IRCT 2015-09-17 Tehran University of Medical Sciences Efficacy of the Malva sylvestris & Alcea digitata &Plantago Psyllium on prevention of radiation induced xerostomia in head and neck cancer patients Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced xerostomia in head and neck cancer patients 2015-09-16 anticipated 44 Complete https://irct.ir/trial/14998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Radiation induced xerostomia. Intervention 1: 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. Intervention 2: 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.
public Ghazaleh Heydarirad
Faculty of Traditional Medicine, west. Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21229885512 dr.ghazalrad@sbmu.ac.ir Tehran University of Medical Sciences scientific Ghazaleh Heydarirad
Faculty of Traditional Medicine, west. Jamali, Vafamanesh st., Heravi sq., Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21229885512 dr.ghazalrad@sbmu.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 17 years 65 years Both K11.7 Dry mouth, unspecified Treatment - Drugs Placebo 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. 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. 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). Quality of life. Timepoint: Before interventin and 2 and 6 weeks after finishing radiation therapy. Method of measurement: EORTC questionnaire. Tehran University of Medical Sciences Approved 2015-03-04 Tehran University of Medical Sciences Keshavarz boulevard, Tehran University of Medical Sciences, Tehran Tehran Iran (Islamic Republic of)