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

NCT ID: NCT04700475

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2021-02-28

Brief 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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

low level laser

Intervention Type: DEVICE

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 .

citric acid solution

Intervention Type: DRUG

citric acid solution applied as a mouth rinse

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

Group Type: OTHER

citric acid solution

Intervention Type: DRUG

citric acid solution applied as a mouth rinse

Interventions

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 .

Intervention Type: DEVICE

citric acid solution

citric acid solution applied as a mouth rinse

Intervention Type: DRUG

Other Intervention Names

cold or non invasive laser

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nada Yousef

OTHER

Sponsor Role: lead

Responsible Party

Nada Yousef

Assistant lecturer of physical therapy, cairouniversity

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cairo university

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nada M. Yousef, master

Role: CONTACT

dr.nada123.ny@gmail.com

01002010168 ext. 01069207280

Mohamed M. Mosaad, bachelor

Role: CONTACT

01000681256

Facility Contacts

Nada M. Yousef, master

Role: primary

dr.nada123.ny@gmail.com

01002010168 ext. 01069207280

Other Identifiers

P.T.REC/012/002269

Identifier Type: -

Identifier Source: org_study_id