Head and Neck CancerNCT05614843
Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy
A study testing Energy density photobiomodulation (7.5) in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Universidad de Granada at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
- What is being tested?
- Energy density photobiomodulation (7.5)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy
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).
Read the 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.
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
- Being tested
- Energy density photobiomodulation (7.5), Sham placebo
- Keywords
- Quality of Life, Neoplasms, Xerostomia, Low-Level Light Therapy
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy density photobiomodulation (7.5)Device
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).
Sham placeboDevice
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).
| Study group | Role | What they receive |
|---|---|---|
| PBM group | Experimental | Energy density 7.5 J / cm2 Receives: Device: Energy density photobiomodulation (7.5) |
| Control group | Placebo comparator | 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. Receives: Device: Sham placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Xerostomia severity.
Xerostomia Inventory consists of 11 items, the total score ranges from 11 to 55 points, and represents the severity of chronic xerostomia. Higher scores mean a worse outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Salivary flow rate.
Determines the amount of unstimulated saliva (ml) produced in 3 minutes. Higher amount means less hyposalivation.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
General and specific quality of life in patients with head and neck cancer.
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 assesses overall quality of life. It is a valid questionnaire and widely used in cancer population. High score for functional scales and global health status represents better outcomes. Higher symptom scales/items scores mean a worse outcome. In addition, its specific head and neck module (EORTC QLQ-H\&N35) where higher symptom scales/items scores mean a worse outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Nutritional and oral status.
Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Maximum mouth opening.
Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary outcomes (7)
Pressure pain threshold.
Using a digital algometer in C5-C6 joint, upper trapezius, levator scapulae, masseter, temporalis, sternoclavicular joint and the tibialis anterior (distal point). Higher values mean higher pain pressure threshold.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Fitness Scale.
The International Fitness Scale (IFIS) assesses overall fitness, cardio-respiratory, muscular, speed and flexibility dimensions using a 5-point Likert scale ('very poor', 'poor', 'average', 'good' and 'very good'). Higher scores mean a better outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Mood status.
The Spanish version of the Scale for Mood Assessment (EVEA) assesses mood state with a range of 0 to 10. It consists of 4 subscales: sadness-depression, anxiety, anger-hostility and happiness. Higher scores mean a worse outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Quality of sleep.
The Pittsburgh Sleep Quality Index will be used to evaluate the perceived quality of sleep in its Spanish version. Higher scores mean a worse outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Physical activity level.
The International Physical Activity Questionnaire (IPAQ-SF) is a tool that it will be used to evaluate physical activity. Different types of physical activities will be recorded (walking, moderate intensity activities, and vigorous intensity activities) during the last 7 days. More time means more amount of physical activity.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Functional capacity.
Using walked distance (m) during 6-minutes walking test. Longer distance means better outcome.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Risk of falls.
Using time (s) during Test Up and Go (TUG). Less time means less risk of falls.
Measured: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Oct 2022
- Primary completion28 Feb 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia Galiano-Castillo, Universidad de Granada
- Investigators
- Noelia Galiano-Castillo, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614843
- Sponsor's protocol ID
- PBM_CANCER
- Other IDs
- PPJIA2020-15, PI-0187-2021
- Status last verified
- Oct 2023
- First submitted
- 6 Nov 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez-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.
PubMed 41013422
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy
- ClinicalTrials.gov ID
- NCT05614843
- Acronym / sponsor ID
- PBM_CANCER
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms, Xerostomia
- Keywords
- Quality of Life, Neoplasms, Xerostomia, Low-Level Light Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PBM group | Experimental | Device: Energy density photobiomodulation (7.5)Energy density 7.5 J / cm2 |
| Control group | Placebo comparator | Device: Sham placeboThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | PBM group |
| Sham placeboA total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). | Device | Control group |
Primary outcome
Xerostomia severity.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Xerostomia Inventory consists of 11 items, the total score ranges from 11 to 55 points, and represents the severity of chronic xerostomia. Higher scores mean a worse outcome.
Salivary flow rate.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Determines the amount of unstimulated saliva (ml) produced in 3 minutes. Higher amount means less hyposalivation.
General and specific quality of life in patients with head and neck cancer.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0 assesses overall quality of life. It is a valid questionnaire and widely used in cancer population. High score for functional scales and global health status represents better outcomes. Higher symptom scales/items scores mean a worse outcome. In addition, its specific head and neck module (EORTC QLQ-H\&N35) where higher symptom scales/items scores mean a worse outcome.
Nutritional and oral status.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Assesses through a Eating Assessment Tool questionnaire (EAT-10). Higher scores mean a worse outcome.
Maximum mouth opening.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Determine maximum mouth opening (mm) as the inter-incisor distance using a sliding caliper. More distance means better mobility.
7 secondary outcomes
Pressure pain threshold.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Fitness Scale.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Mood status.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Quality of sleep.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Physical activity level.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Functional capacity.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Risk of falls.
Time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 41013422Lopez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noelia Galiano-Castillo, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy density photobiomodulation (7.5) in people with Head and Neck Cancer and Head and Neck Neoplasms, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia severity. (time frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05614843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.