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

Nada Yousef

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Drug: citric acid solution; Device: low level laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04700475

P.T.REC/012/002269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Laser group

Experimental group

Description:

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

Treatment:

Device: low level laser

Drug: citric acid solution

Control group

Other group

Description:

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

Treatment:

Drug: citric acid solution