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

NCT02854358 | Completed Phase 2

• 1 other identifier: CT.9732
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Xerostomia; Head and Neck Cancers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

control

ACTIVE COMPARATOR

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

Drug: Hypozalix spray (artificial saliva)

intervention

EXPERIMENTAL

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

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

Interventions

mixed powder of A. digitata and M. sylvestris DRUG

Also known as: Traditional Persian Medicine preparation

intervention

Hypozalix spray (artificial saliva) DRUG

Hypozalix spray (artificial saliva)

control

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead
• Shahid Beheshti University of Medical Sciences: collaborator

Related Publications (1)

• Heydarirad G, Rezaeizadeh H, Choopani R, Mosavat SH, Ameri A. Efficacy of a traditional Persian medicine preparation for radiation-induced xerostomia: a randomized, open-label, active-controlled trial. J Integr Med. 2017 May;15(3):201-208. doi: 10.1016/S2095-4964(17)60333-9.

  PMID: 28494850 DERIVED

MeSH Terms

Conditions

Xerostomia; Head and Neck Neoplasms

Interventions

Saliva, Artificial

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Mouthwashes; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: August 3, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 3, 2016

Record last verified: 2016-07