Radiation induced xerostomia. Dry mouth, unspecified
Conditions
Interventions
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 continu
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
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.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
17 Years to 65 Years
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Before interventin and 2 and 6 weeks after finishing radiation therapy. Method of measurement: EORTC questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGhazaleh Heydarirad
Tehran University of Medical Sciences
Outcome results
None listed