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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614843
• Other study ID #: PBM_CANCER
• Secondary ID: PPJIA2020-15PI-0
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 31, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Spain	Faculty of Health Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and adverse events	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).
Other	Satisfaction questionnaire.	Each patient will mark his/her experience after PBM therapy. Higher scores mean a better outcome.	12 weeks (after intervention).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary	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.	Change from Baseline to 12 weeks (after intervention) and to 6 months (follow-up).
Secondary	Functional capacity.	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).
Secondary	Risk of falls.	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).