Trials / Recruiting
RecruitingNCT05106608
Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Universidad de Granada · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Many experts advocate the use of Photobiomodulation (PBM) therapy in patients with cancer and demand studies of higher methodological quality such as randomized controlled clinical trials. However, there is no consensus on the most effective dosimetry that allows us to establish an effective and safe approach to treat radiotherapy-induced xerostomia in head and neck cancer survivors. Finally, recent reviews highlight the importance of determining whether or not the effects of Photobiomodulation therapy are maintained after a follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Energy density photobiomodulation (7.5) | A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided. |
| DEVICE | Energy density photobiomodulation (3) | A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided. |
| DEVICE | Sham placebo | In addition, a mobile health application (LAXER) will be provided. |
Timeline
- Start date
- 2022-07-13
- Primary completion
- 2026-07-01
- Completion
- 2026-12-01
- First posted
- 2021-11-04
- Last updated
- 2026-01-05
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05106608. Inclusion in this directory is not an endorsement.