Efficacy of Traditional Persian Medicine Preparation Versus Artificial Saliva for Radiation Induced Xerostomia

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Xerostomia; Head and Neck Cancers

Treatments: Drug: Hypozalix spray (artificial saliva); Drug: mixed powder of A. digitata and M. sylvestris

Study type: Interventional

Funder types: Other

Identifiers

NCT02854358

CT.9732

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

control

Active Comparator group

Description:

In the control group, patients received Hypozalix (artificial saliva)spray three times per day for a period of four weeks.

Treatment:

Drug: Hypozalix spray (artificial saliva)

intervention

Experimental group

Description:

Patients in intervention group received sachets containing 4 grams of mixed powder of A. digitata and M. sylvestris (in a proportion of 1:1), three times per day for a period of four weeks

Treatment:

Drug: mixed powder of A. digitata and M. sylvestris