Clinical trial · Interventional
Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy
NCT05614843CI-TRIAL-00070310completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Patients with head and neck cancer post-radiotherapy may improve their perceived and amount of saliva after a 3-month Photobiomodulation (PBM) therapy focuses on three main salivary glands (parotid, submandibular and sublingual glands).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Energy density photobiomodulation (7.5) | Device | — | UNRESOLVED |
| Sham placebo | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PBM group
- description
- Energy density 7.5 J / cm2
- interventionNames
- Device: Energy density photobiomodulation (7.5)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective goggles) using the same laser device to imitate a real irradiation; however, the device will be turned off and recording of the emission sounds will be used to give the patient the hearing sensation of the PBM therapy.
- interventionNames
- Device: Sham placebo
Primary outcomes (5)
- measure
- Xerostomia severity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with head and neck cancer * Persistent xerostomia after radiotherapy * ≥18 years * Irradiated with radiotherapy in the major salivary glands (parotid, submandibular and sublingual) * Grade 3 for dry mouth in Common Terminology Criteria for Adverse Events, CTCAE (version 5.0) * Have completed medical treatment with full response (complete remission) and receive medical clearance for participation. * At least one month after radiotherapy completion, to reflect the possible presence of oral mucositis (sores) and/or radiodermatitis (inflammation) that limits adherence to treatment * No use of drugs/devices/products (pilocarpine, cevimeline, amifostine, oral devices, humidifiers or herbs) to prevent or treat xerostomia before inclusion in the study, OR constant usage (do not change type and dosage) during 2 months before inclusion in the study Exclusion Criteria: * Relapse or metastasis * Karnofsky activity scale \<60 * Contraindications to PBM therapy (cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, pregnancy) * Patients with other comorbidities such as diabetes o polymedication
References
Publications (1)
- DERIVEDLopez-Garzon M, Plata-Peregrina MDC, Perez-Sanchez EI, Lozano-Lozano M, Artacho-Cordon F, Galiano-Castillo N. Photobiomodulation for restoring salivary flow after radiotherapy in head and neck cancer: a randomised placebo-controlled trial. BMC Oral Health. 2025 Sep 26;25(1):1468. doi: 10.1186/s12903-025-06735-3. PMID 41013422