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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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 : 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.

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

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Device: low level laser
* Drug: citric acid solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the study, 2 groups of patients will participate First, study group will recieve low level laser on major salivary glands and usual medications. Second, control group will recieve usual medications. Second, control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser group<br>Laser group composes of thirty patients who will receive low level 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 | Device: low level laser<br>* 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 .<br>* Other names: cold or non invasive laser;Drug: citric acid solution<br>* citric acid solution applied as a mouth rinse<br>|
| Other: Control group<br>control group composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec | Drug: citric acid solution<br>* citric acid solution applied as a mouth rinse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low level laser, Xerostomia, Radiotherapy, Head and neck cancer