Xerostomia Clinical Trial
Verified date | July 2016 |
Source | Shiraz University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
Head and neck cancers(HNC) is one of the most common cancers worldwide. Xerostomia is one of
the most common side effect of radiation therapy among patients with HNC. Mouth dryness
significantly impairs patients' quality of life (QOL).
HNC.Regarding to traditional use of A. digitata and M. sylvestris in addition to known their
beneficial effects in recent studies, we decided to design a randomized, controlled clinical
trial to try to evaluate efficacy of the these herbs in QOL of HNC patients with radiation
induced xerostomia
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - patients with head and neck cancer who had grade 1 and 2 xerostomia (based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0) and finished radiotherapy at least two months before the study(22). Exclusion Criteria: - history of connective tissue disorder (e.g., Sjogren) other medical causes of xerostomia (such as diabetes, bowel and renal diseases), using antidepressants drugs, recurrence of cancer, end stage cancer, pregnancy, lactation history of hypersensitivity or allergy to A. digitata and M. sylvestris |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shiraz University of Medical Sciences | Shahid Beheshti University of Medical Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in patients' quality of life | changes in patients' quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire|(EORTC QLQ-H&N 35) | 4 weeks | Yes |
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