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NCT Number: NCT05614843

Photobiomodulation Therapy 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).

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences

Granada, 18016, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 placebo

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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.

  2. Satisfaction questionnaire.

    Time frame: 12 weeks (after intervention).

    Each patient will mark his/her experience after PBM therapy. Higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Pilot Study Evaluating the Impact of a Photobiomodulation Therapy on Xerostomia and Hyposalivation in Patients With Head and Neck Cancer Post-Radiotherapy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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