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New treatment option for Head and Neck Cancer
Official title Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study
ClinicalTrials.gov ID: NCT05106608
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will be included in the study if they meet the following
- 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).
You likely can't join if
- 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...
- other comorbidities such as diabetes and polypharmacy.
- and retraction of the declaration of consent.
See the full eligibility criteria
- Patients will be included in the study if they meet the following
- 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...
- and able to access mobile applications or living with someone who has this ability. The
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Granada, Granada, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Granada, Granada, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.