Using light therapy and mobile health to improve quality of life in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Faculty of Health Sciences
  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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.