Clinical trial · Interventional
Effect of Low-level Laser Therapy on Salivary Flow, pH and Quality of Life in Irradiated Oropharyngeal Cancer Patients
Effect of Low-level Laser Therapy on Salivary Flow, pH and Quality of Life in Irradiated Oropharyngeal Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-Level Laser Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Low level Laser Therapy Group
- description
- 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.
- interventionNames
- Radiation: Low-Level Laser Therapy
Primary outcomes (3)
- measure
- Increase in Salivary flow rate
- timeFrame
- 12 weeks
- description
- Increase in salivary flow rate in patients who have undergone Radiation therapy for oropharyngeal cancers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
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