An interventional study of low level laser and citric acid solution in Head and Neck Cancer, sponsored by Nada Yousef. Status unknown at 1 site in Egypt. Open to participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Nada Yousef · Not applicable, Interventional, and Prevention
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.
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 :
1-Therapeutic equipment: Laser therapy will be performed with an GaAlAs laser
2- Evaluation tools:
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's planned enrollment of 60 is above the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
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Exclusion Criteria:
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 · Drug: citric acid solution
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
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 .
Also known as: cold or non invasive laser
citric acid solution applied as a mouth rinse
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
Time frame: 7 weeks
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.
Time frame: 7weeks
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.
Time frame: 7weeks
Plan to share: No
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