NCT05106608 Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
| NCT ID | NCT05106608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Granada |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-07-13 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-07-13 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.
Eligibility 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.
Contact & Investigator
Noelia Galiano-Castillo, PhD
PRINCIPAL INVESTIGATOR
Universidad de Granada
Frequently Asked Questions
Who can join the NCT05106608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05106608 currently recruiting?
Yes, NCT05106608 is actively recruiting participants. Contact the research team at noeliagaliano@ugr.es for enrollment information.
Where is the NCT05106608 trial being conducted?
This trial is being conducted at Granada, Spain.
Who is sponsoring the NCT05106608 clinical trial?
NCT05106608 is sponsored by Universidad de Granada. The principal investigator is Noelia Galiano-Castillo, PhD at Universidad de Granada. The trial plans to enroll 60 participants.
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