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

NCT04700475 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-01-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

low level laser

Laser will be performed with a GaAlAs diode laser at a wavelength of 808 nm, 100-mW output power, laser beam area of 0.03 cm2, and in continuous wave mode, three times a week, on alternate days. Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions. The total energy per session (56 J) will be divided into 14 irradiation points, as marked on the overlying skin (Fig.2). Each irradiation point received a dose of 4 J over an irradiation time of 40 s. With exclusion of tumor area or area of removed tumor laser will be applied as following: • Extra oral application: The laser will be used extraorally at eight points in the parotid glands (bilaterally, four points in each gland), at four points in the submandibular glands (bilaterally, two points in each gland • Intraoral application: The will be used intraorally at two points in the sublingual glands bilaterally, one point in each gland .

DRUG

citric acid solution

citric acid solution applied as a mouth rinse

Sponsors & Collaborators

  • Nada Yousef

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2020-11-01
Completion
2021-02-28

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04700475 on ClinicalTrials.gov