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
- Conditions
- Radiation induced xerostomia.Dry mouth, unspecified
- Registration Number
- IRCT2014012415860N1
- Lead Sponsor
- School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center,Shahid Behes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
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.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).;Quality of life. Timepoint: Before interventin and 4 weeks after intervention. Method of measurement: EORTC questionnaire.
- Secondary Outcome Measures
Name Time Method Other Symptoms. Timepoint: Before interventin and 4 weeks after intervention. Method of measurement: Question from patient.