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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04700475
• Other study ID #: P.T.REC/012/002269
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: February 2021

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: Nada M. Yousef, master
• Phone: 01002010168
• Email: dr.nada123.ny[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• - Age range between 25-55 years.

• All patients included in the study established HNC and will receive radiotherapy encompassing major salivary glands accompanied or not by surgery.

• All patients enrolled to the study will have their informed consent.

• Both genders will participate in the study.

• All the patients were examined medically by oncologist

Exclusion Criteria:

• - Diabetes mellitus,

• Autoimmune diseases as sjorgen syndrome by established diagnosis criteria.

• Infectious diseases

• Collagen diseases, as were those with incipient tumors (stage T1 or T2) limited to the larynx, as well as those with trismus (reduced mouth opening capacity) due to surgical sequelae.

• xerostomic drugs (antiretroviral medications, antihistamines, anticholinergics, antihypertensives, decongestants, narcotic analgesics, tricyclic antidepressants)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Nada Yousef

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The 11-item modified Xerostomia Inventory-Dutch questionnaire version	The XI is an 11-item summated rating scale that was developed to measure the severity of dry mouth symptoms. The final score ranges from 5 to 55, with higher scores indicating more severe symptoms. A decrease in XI scores of 6 points or more between pre- and post-treatment assessments will be considered clinically significant.; The mean dry mouth score and the correlation between dry mouth score and salivary flow rate will be analysed.	7weeks
Primary	Unstimulated and stimulated salivary flow rate.	For the assessment of salivary flow rate, unstimulated and stimulated sialometry tests will be performed before the first radiotherapy session and after completion of laser programe.; As salivary secretion fluctuates between minimal and maximal rates during the day, it is important to assess the salivary secretion consistently at an established time of the day, in order to properly examine the evolution of the condition and its treatment in every patient.; The normal flow rate for unstimulated, "resting" whole saliva is 0.3 to 0.5 ml/min.; for stimulated saliva, 1 to 2 ml/min. Values less than 0.1 ml/min. are typically considered xerostomic, although reduced flow may not always be associated with complaints of dryness	7 weeks
Secondary	Salivary immunoglobin A (sIgA) concentration in unstimulated saliva.	The samples of unstimulated whole saliva will be frozen and stored at -20°C until used for sIgA determination. sIgA concentrations were measured by using commercially available indirect competitive enzyme immunoassay kit (Salivary SIgA EIA kit, Salimetrics).; The quantities of salivary IgA secreted in 5 minutes will be calculated by taking in account sIgA concentrations and volumes of unstimulated saliva secreted in 5 minutes.	7weeks