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Completed

NCT Number: NCT05538169

The Management of RT-induced Hyposalivation Using LLLT

The primary purpose is to evaluate the effectiveness of photobiomodulation laser application in the management of patients with radiotherapy-induced hyposalivation. Secondary, to assess the changes in the scores of the patient's oral health-related quality of life using validated measurements.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Saud Universiry

Riyadh, 11472, Saudi Arabia

About this study

Head and neck cancer is a general term used to describe epithelial malignancies in the oral cavity, paranasal sinuses, nasal cavity, pharynx, and larynx. These malignancies are often presented as squamous cell carcinoma (SCC) of the head and neck with tobacco and alcohol consumption remaining the two main risk factors. In addition, human papillomavirus has been identified as another risk factor in a limited subset of these malignancies. More specifically, oral cancer accounts for 2%-4% of all cancer worldwide with 90% of these cases presented as SSC worldwide compared to 44.8% in Saudi Arabia. Clinically, patients often presented with white and/or red patches, hoarseness, non-healed ulcers, throat pain, and painless cervical lump which may persist for more than 3 weeks period.

Most head & neck cancer patients who received radiotherapy are likely to experience xerostomia and salivary glands hypofunction, mucositis, and possibly the loss of taste.

Furthermore, the effect of hyposalivation is not only limited to taste dysfunction but also associated with opportunistic infections, difficulty in chewing and speaking, rapid progression of caries, and oral mucositis. All these secondary complications are usually associated with pain and discomfort which will heavily affect the patient quality of life if they are untreated. Treatment options include moisturizing agents or artificial saliva which have a palliative effect however they are not preferred nor accepted by most patients.

The outcome of low-level laser therapy usage on cancer patients is well documented and well established in the literature. The vast majority of the results suggest that this therapy is an effective treatment option to stimulate salivary glands flow and decrease xerostomia/hyposalivation symptoms. In the present study, the efficiency of this treatment option will be tested as well as the changes in the patient's quality of life during and after the radiation treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 and above
  • Clinically diagnosed with hyposalivation [an unstimulated salivary flow rate of ≤ 0.1ml per minute] (31) due to recent radiation therapy of SCC of the head and neck.

Exclusion criteria

  • Individuals with systemic diseases that could affect the salivary glands function such as (e.g. Sjogren syndrome) and medications (e.g. beta-blockers and diuretics for hypertension).
  • Individuals who had an allergy to toluidine blue stain.

Treatment and study plan

low-level laser diode (Pioon Laser)

Device

Settings: the spot tip area of this tool is 0.088 cm2, semi-conductor diode, with a wavelength of 980 nm (near infrared), 200 mW output power, 1.97W/cm2 of power density, 3 J energy per point and application time 15 seconds per point].

  • PBM will apply punctually, in continuous emissions.
  • Extra-oral points: six points on each parotid gland, three points on each submandibular gland.
  • Intra-oral points: two points on each sublingual gland.
  • A total of 22 points will be applied in each session.

Primary outcomes

  1. Unstimulated and stimulated salivary flow rate

    Time frame: 12 weeks

    The unstimulated and stimulated salivary flow rate (ml/minute) will be collected at three different time periods: (T1) the first visit and before applying the laser, (T2) the 8th visit and after using the laser, and (T3) the re-evaluation visit after two months.

Secondary outcomes

  1. Xerostomia assessment

    Time frame: 12 weeks

    Xerostomia will be analysed at (T1) first visit, (T2) 8th visit, and (T3) at the re-evaluation visit using the Arabic version of Xerostomia Inventory, which is assessed by a 4-point scale (from never = 0 to always = 3).

  2. Dysgeusia assessment

    Time frame: 12 weeks

    Dysgeusia will be analysed at (T1) first visit, (T2) 8th visit, and (T3) at the re-evaluation visit using the 11-item Dysguesia Questionnaire, which is assessed by a mix of choices (e.g. yes or no) and 4-point scale for each question (little, tolerably, a lot or don't rememeber).

  3. Quality of life assessment

    Time frame: 12 weeks

    The Oral health-related quality of life (OHQoL) will be measured at (T1) first visit, (T2) 8th visit, and (T3) at the re-evaluation visit using the validated Arabic version of Oral Health Impact Profile (OHIP-5), which is which is assessed by a 5-point scale (from never = 0 to always = 4).

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Registry information

Official study title

The Management of Radiotherapy-induced Hyposalivation Using Low-level Laser Therapy: A Case Series.

Acronym: REACH-LLLT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 13, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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