- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05538169
The Management of RT-induced Hyposalivation Using LLLT (REACH-LLLT)
The Management of Radiotherapy-induced Hyposalivation Using Low-level Laser Therapy: A Case Series.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdullah M Alsoghier, PhD
- Phone Number: +966555881433
- Email: aalsoghier@ksu.edu.sa
Study Contact Backup
- Name: Asma Faden
- Email: afaden@ksu.edu.sa
Study Locations
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-
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Riyadh, Saudi Arabia, 11472
- King Saud Universiry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laser therapy group
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
|
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].
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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12 weeks
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Dysgeusia assessment
Time Frame: 12 weeks
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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).
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12 weeks
|
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).
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12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KingSaudU-E-21-6045
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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