Head and Neck Cancers, Xerostomia
Conditions
Brief summary
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
Interventions
DRUGmixed powder of A. digitata and M. sylvestris
DRUGHypozalix spray (artificial saliva)
Hypozalix spray (artificial saliva)
Sponsors
Shahid Beheshti University of Medical Sciences
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in patients' quality of life | 4 weeks | 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) |
Outcome results
None listed