Effect of Low-level Laser Therapy on Salivary Flow, pH and Quality of Life in Irradiated Oropharyngeal Cancer Patients

NCT04738227 | Completed DMC

• 1 other identifier: 2480820DAOM
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

There are multiple treatment modalities for head and neck cancer. They include radiation therapy, chemotherapy and surgery. Radiation therapy aims to control the tumor with minimum damage to adjacent tissues. Surgery is the preferred treatment for accessible cancers. Radiation and/or chemotherapy is used as an adjunct to surgery, in inaccessible tumors, post surgery sterilization and palliation. A major complication of RT is that adjacent normal tissues are variably affected. For Oropharyngeal cancer, major and minor salivary glands are damaged by RT since they fall in the radiation pathway. Atrophy and acinar degeneration are features most commonly found histologically. Xerostomia is defined as dry mouth resulting from reduced or absent saliva flow. Xerostomia is not a disease, but may be a symptom of various medical conditions, a side effect of a wide variety of medications and a side effect of a radiation to the head and neck.The flow rate of normal unstimulated saliva is 0.3-0.5 ml/min. If it decreases to less than 0.1-0.2 ml/min, one would experience xerostomia. According to researchers, the decrease in saliva and xerostomia that results from radiotherapy plays an important role in worsening Quality of Life(QoL) among patients who undergo radiotherapy for head and neck cancers. Low level laser Therapy(LLLT) uses light energy in the form of photons to produce cellular responses in the cell. Light photons are absorbed by cytochromes and porphyrins in the mitochondria of the cell. This study aims to prove that Low level laser therapy will improve salivary flow rate, pH and the quality of life in patients who have undergone Radiation therapy for oropharyngeal cancers.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (3)

• Increase in Salivary flow rate

  Increase in salivary flow rate in patients who have undergone Radiation therapy for oropharyngeal cancers.

  12 weeks

• Increase in pH

  Increase in pH in patients who have undergone Radiation therapy for oropharyngeal cancers.

  12 weeks

• Increase in Quality of Life questionnaire Score

  Increase in the quality of life in patients who have undergone Radiation therapy for oropharyngeal cancers. The questionnaire has 13 close ended questions. The total score of the questionnaire will be between 0-1300 A higher score will indicate improvement in the quality of life and will be compared with the score taken at baseline, before the start of the study.

  12 weeks

Study Arms (1)

Low level Laser Therapy Group

EXPERIMENTAL

Laser therapy will be performed with a continuous wave diode laser device previously calibrated by the manufacturer. 6 points that will be the skin overlying the right hand side parotid gland and 3 points on the skin overlying the location of the right hand side submandibular gland). Following are the parameters which will be employed for the laser: Wavelength - 635nm (visible spectrum), Output power 100 milliwatt, Mean dose per point - 3 J/cm2 , Irradiation time per point 15 s Energy per point 3 J Energy per session 60 J , Laser spot tip will be 0.08cm2 Two laser sessions will be done each week, during 12 weeks, which will bring the total number of laser sessions to All the major salivary glands will be treated with the tip of the laser hand-piece in contact with patients tissues. A sum total of 22 points will receive LLLT per session involving all three major salivary glands.

Radiation: Low-Level Laser Therapy

Interventions

Low-Level Laser Therapy RADIATION

Low level laser will be applied and post laser results will be seen to assess any improvements.

Low level Laser Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiation induced persistent xerostomia which will be confirmed clinically and by taking salivary flow rate. Patients which will have salivary flow rate less than 0.1-0.2 ml/min shall be included.
• Patients treated with therapeutic RT for oropharyngeal cancers 3 to 36 months ago
• Patients whose age was equal to or more than 18 years irrespective of gender.

You may not qualify if:

• Patients with other determined causes of xerostomia which have been confirmed. Systemic conditions (specially checking and excluding patients having dehydration,patients with known diseases of salivary glands, salivary glands removal surgery, smoking, diabetes, and autoimmune disorders among such as Sjögren's syndrome and drugs that cause xerostomia.

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, 75500, Pakistan

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Danial Arshad, M.Phil

  Ziauddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 4, 2021
• Study Start: November 6, 2020
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)