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

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: low level laser; Drug: citric acid solution

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada M. Yousef, master; Phone Number: 01069207280 01002010168; Email: dr.nada123.ny@gmail.com
• Study Contact Backup: Name: Mohamed M. Mosaad, bachelor; Phone Number: 01000681256

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo University
    • Contact: Nada M. Yousef, master; Phone Number: 01069207280 01002010168; Email: dr.nada123.ny@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser group; 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; 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 .; Other Names: cold or non invasive laser; Drug: citric acid solution; citric acid solution applied as a mouth rinse
Other: Control group; 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; citric acid solution applied as a mouth rinse

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nada Yousef

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Radiotherapy; Xerostomia; Head and neck cancer; Low level laser
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Xerostomia; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: P.T.REC/012/002269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No