Head and Neck CancerREACH-LLLTNCT05538169
The Management of RT-induced Hyposalivation Using LLLT
A study testing low-level laser diode (Pioon Laser) in people with Head and Neck Cancer, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- low-level laser diode (Pioon Laser)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Jan 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Management of Radiotherapy-induced Hyposalivation Using Low-level Laser Therapy: A Case Series.
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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- low-level laser diode (Pioon Laser)
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy group | Experimental | There will be 2 weekly applications of a low-level laser diode (Pioon Laser) for a 4-week active treatment period. Thus, a total of 8 therapeutic sessions will be conducted Receives: Device: low-level laser diode (Pioon Laser) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unstimulated and stimulated salivary flow rate
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.
Measured: 12 weeks
Secondary outcomes (3)
Xerostomia assessment
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).
Measured: 12 weeks
Dysgeusia assessment
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).
Measured: 12 weeks
Quality of life assessment
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start3 Jan 2022
- Primary completion1 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective case series of patients who have received radiotherapy for SCC of the head and neck
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abdullah Mohamed Alsoghier, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538169
- Sponsor's protocol ID
- KingSaudU-E-21-6045
- Acronym
- REACH-LLLT
- Status last verified
- Oct 2023
- First submitted
- 8 Sep 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alsoghier A, Mutaieb S, Bukhari A, AlQarni M, Alhazzaa S, Aljabab S, Alsuhaibani A, Faden A. Management of radiotherapy-induced hyposalivation using photobiomodulation therapy: a case series. Lasers Med Sci. 2025 Jan 20;40(1):25. doi: 10.1007/s10103-025-04292-3.
PubMed 39833441
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Radiotherapy-induced Hyposalivation Using Low-level Laser Therapy: A Case Series.
- ClinicalTrials.gov ID
- NCT05538169
- Acronym / sponsor ID
- REACH-LLLT / KingSaudU-E-21-6045
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective case series of patients who have received radiotherapy for SCC of the head and neck
| Arm | Type | Receives |
|---|---|---|
| Laser therapy group | Experimental | Device: low-level laser diode (Pioon Laser)There will be 2 weekly applications of a low-level laser diode (Pioon Laser) for a 4-week active treatment period. Thus, a total of 8 therapeutic sessions will be conducted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-level laser diode (Pioon Laser)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. | Device | Laser therapy group |
Primary outcome
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.
3 secondary outcomes
Xerostomia assessment
Time frame: 12 weeks
Dysgeusia assessment
Time frame: 12 weeks
Quality of life assessment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39833441Alsoghier A, Mutaieb S, Bukhari A, AlQarni M, Alhazzaa S, Aljabab S, Alsuhaibani A, Faden A. Management of radiotherapy-induced hyposalivation using photobiomodulation therapy: a case series. Lasers Med Sci. 2025 Jan 20;40(1):25. doi: 10.1007/s10103-025-04292-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser diode (Pioon Laser) in people with Head and Neck Cancer, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unstimulated and stimulated salivary flow rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05538169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.