Photobiomodulation Therapy in Patients With Head and Neck Cancer Post-Radiotherapy

October 9, 2023 updated by: Noelia Galiano-Castillo, Universidad de Granada

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Granada, Spain, 18016
        • Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PBM group
Energy density 7.5 J / cm2
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).
Placebo Comparator: Control group
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.
Device: Sham placebo
A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
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.
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
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.
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.
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.
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
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.
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pressure pain threshold.
Time Frame: Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
Using walked distance (m) during 6-minutes walking test. Longer distance means better outcome.
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).
Using time (s) during Test Up and Go (TUG). Less time means less risk of falls.
Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and adverse events
Time Frame: 12 weeks (after intervention).
Each adverse event is characterized by severity (grade 1 [mild] to 5 [death]), expectation (expected or unexpected) and potential relationship with participation in our study (unrelated, possibly related, or related to the study) using Common Terminology Criteria for adverse events (version 5.0). Higher scores mean a worse outcome.
12 weeks (after intervention).
Satisfaction questionnaire.
Time Frame: 12 weeks (after intervention).
Each patient will mark his/her experience after PBM therapy. Higher scores mean a better outcome.
12 weeks (after intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noelia Galiano-Castillo, PhD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PBM_CANCER
  • PI-0187-2021 (Other Grant/Funding Number: Conserjeria de Salud y Familias (Junta de Andalucía))
  • PPJIA2020-15 (Other Grant/Funding Number: Universidad de Granada)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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