Using light therapy and mobile health to improve quality of life in head and neck cancer patients
Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
This study is testing whether light therapy can help improve the quality of life and oral health for people who have survived head and neck cancer and are dealing with dry mouth from radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada, Granada) |
| Trial ID | NCT05106608 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Photobiomodulation (PBM) therapy on quality of life and oral health in survivors of head and neck cancer who have undergone radiotherapy. It aims to determine the most effective dosimetry for treating chronic xerostomia, a common side effect of radiation treatment. Participants will receive different energy densities of PBM therapy or a sham placebo, with follow-up assessments to evaluate the sustainability of any improvements. The study emphasizes the need for high-quality randomized controlled trials in this area.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with head and neck cancer who experience chronic xerostomia after radiotherapy.
Not a fit: Patients who have used medications or devices to treat xerostomia prior to the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life for head and neck cancer survivors suffering from xerostomia.
How similar studies have performed: Previous studies have shown promising results with Photobiomodulation therapy in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients will be included in the study if they meet the following inclusion criteria: * men or women aged 18 years or older and were diagnosed with HNC. * chronic xerostomia. * received RT in the parotid, submandibular and/or sublingual salivary glands. * grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE). * medical treatment completed and in complete remission. * received medical clearance for participation in this study. * at least one month passed since the end of RT to avoid the possible presence of oral mucositis and/or radiodermatitis, which limits adherence to treatment and maximum 36 months. * no history of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion. * and able to access mobile applications or living with someone who has this ability. The exclusion criteria will be as follows: * patients with metastases. * a score \<60 on the Karnofsky Performance Status Scale. * contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy). * other comorbidities such as diabetes and polypharmacy. * and retraction of the declaration of consent.
Where this trial is running
Granada, Granada
- Faculty of Health Sciences — Granada, Granada, Spain (Recruiting)
Study contacts
- Principal investigator: Noelia Galiano-Castillo, PhD — Universidad de Granada
- Study coordinator: Noelia Galiano-Castillo, PhD
- Email: noeliagaliano@ugr.es
- Phone: 699197690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.