NCT05614843

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

November 6, 2022

Last Update Submit

October 9, 2023

Conditions

Head and Neck CancerHead and Neck NeoplasmsXerostomia

Keywords

Quality of LifeNeoplasmsXerostomiaLow-Level Light Therapy

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

Secondary Outcomes (7)

  • Pressure pain threshold.

    Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

  • Fitness Scale.

    Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

  • Mood status.

    Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

  • Quality of sleep.

    Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

  • Physical activity level.

    Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).

  • +2 more secondary outcomes

Other Outcomes (2)

  • Safety and adverse events

    12 weeks (after intervention).

  • Satisfaction questionnaire.

    12 weeks (after intervention).

Study Arms (2)

PBM group

EXPERIMENTAL

Energy density 7.5 J / cm2

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.

Device: Sham placebo

Interventions

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).

PBM group
Sham placeboDEVICE

A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total).

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Granada, 18016, Spain

Location

Related Publications (1)

  • 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.

    PMID: 41013422DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsXerostomiaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteSalivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Noelia Galiano-Castillo, PhD

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants who meet the inclusion and exclusion criteria will be randomized to one of the two study groups using a random number generation program (www.randomizer.org). The randomization sequence will be prepared by a member external to the investigation to respect the masking in terms of randomization of the participants, thus reducing the risk of bias during the evaluations. Therefore both patients and evaluator will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 14, 2022

Study Start

October 1, 2022

Primary Completion

February 28, 2023

Study Completion

July 31, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

ES(1)