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

NCT04700475 | Unknown

• 1 other identifier: P.T.REC/012/002269
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Low level laser; Xerostomia; Radiotherapy; Head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Salivary immunoglobin A (sIgA) concentration in unstimulated saliva.

  7weeks

Other Outcomes (1)

• The 11-item modified Xerostomia Inventory-Dutch questionnaire version

  7weeks

Study Arms (2)

Laser group

EXPERIMENTAL

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

OTHER

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

Interventions

low level laser 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 .

Also known as: cold or non invasive laser

Laser group

citric acid solution DRUG

citric acid solution applied as a mouth rinse

Control group; Laser group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Nada Yousef: lead

Study Sites (1)

Cairo university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Xerostomia

Interventions

Low-Level Light Therapy; citric acid, deuterium oxide solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Nada M. Yousef, master

CONTACT

01002010168; dr.nada123.ny@gmail.com

Mohamed M. Mosaad, bachelor

CONTACT

01000681256

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participants are head and neck cancer patients recieving radiotherapy. The care provider are oncologist and nursing stuff. The investigator is phsical therapist (my self)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of physical therapy, cairouniversity

Model Details: 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

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: January 8, 2021
• Study Start: September 4, 2020
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2021
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)