Clinical trial NCT05614843: Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
Official title: Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Neoplasms
Xerostomia
Keywords: Quality of Life
Neoplasms
Xerostomia
Low-Level Light Therapy
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The use of PBM therapy in survivors with head and neck cancer may be an effective treatment to improve xerostomia and hyposalivation as side effects of radiotherapy. Although there is some scientific evidence on its benefits during or after radiotherapy, it is not sufficient to establish it as an effective treatment. For these reasons, studies of higher methodological quality such as randomized controlled trials, are needed. This study aims to demonstrate the benefits of PBM therapy on xerostomia and hyposalivation in survivors with head and neck cancer undergone radiotherapy, and whether the effects are maintained after a follow-up period.

Eligibility criteria: 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

Primary outcomes:
measure: Xerostomia severity.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Salivary flow rate.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: General and specific quality of life in patients with head and neck cancer.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Nutritional and oral status.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Maximum mouth opening.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary outcomes:
measure: Pressure pain threshold.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Fitness Scale.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Mood status.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Quality of sleep.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Physical activity level.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Functional capacity.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
measure: Risk of falls.
timeFrame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Other outcomes:
measure: Safety and adverse events
timeFrame: 12 weeks (after intervention).
measure: Satisfaction questionnaire.
timeFrame: 12 weeks (after intervention).
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
affiliation: Universidad de Granada
name: Noelia Galiano-Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: