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Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.

Head and Neck Cancer Clinical Trial

Official title:
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.

Clinical Trial Summary

The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival.

Clinical Trial Description

In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures. 1. Subjects: Sixty patients who have head and neck cancer (oral cavity, pharynx, larynx, or occult primary tumor) submitted to conventional 3D radiotherapy, with irradiation fields necessarily encompassing all major salivary glands. The total dose ranged from 66 to 70 Gy, given in fractions of 2 Gy/day selected randomly from Nuclear medicine department, Oncology institute, Mansoura University. These patients will be divided randomly into two groups of equal number, thirty patients for each group. Group A: (Laser group) This group of patients composes of thirty patients who will receive GaAlAs laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions (Fernanda A. S.G. et al., 2016). Group B :( Control group) This group of patients composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec (Bozana Loncar, D.M.D. et al., 2010) . The criteria of Patients selection : 2. Equipment used: 1-Therapeutic equipment: Laser therapy will be performed with an GaAlAs laser 2- Evaluation tools: - Unstimulated and stimulated saivery flow rate. - Salivery immunoglobin A (sIgA) concentration in unstimulated saliva - The 11-item modified Xerostomia Inventory-Dutch questionnaire version 22. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04700475
Study type Interventional
Source Cairo University
Contact Nada M. Yousef, master
Phone 01002010168
Email dr.nada123.ny@gmail.com
Status Recruiting
Phase N/A
Start date September 4, 2020
Completion date February 2021
View Details
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