Laser Acupoints Stimulation on Xerostomia Related Chemoradiotherapy for Head and Neck Cancer Patients

ConditionsHead and Neck Cancer Xerostomia Following Radiotherapy

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-70

SponsorCairo University

About this trial

The purpose of the study is to evaluate to effect of LASER acupoints stimulations on xerostomia patients during chemoradiation therapy after head and neck cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chemoradiation therapy

Carcinoma in the head and neck area (NPC)

Anatomically intact parotid and submandibular glands.

All patients will be clinically and medically stable when attending the study.

Disqualifiers

They had a history of xerostomia;

They had suspected or confirmed physical closure of salivary gland.

ducts on either side.

They had known bleeding disorders.

Trial design

Design model

Parallel

Treatments tested in this trial

Medical treatment
Other intervention
They will receive oral chemotherapy, based on the cancer stage, and will also undergo radiotherapy.
LASER acupoints therapy
Other intervention
LASER acupoints therapy will use the Pointer Pulse device (GMT2000 s.r.l., Italy), emitting 650 nm red light with an audio trimmer for acupoint detection. Treatment parameters include 5 mW power, 120 s irradiation per point over a 3.14 mm² area (fluence: 19.2 J/cm², power density: 0.16 W/cm², total dose: 0.6 J). Continuous red laser will be applied for effective stimulation. Sessions will occur once weekly for five weeks. Bilateral stimulation will follow this order: left hand, left face, trunk, right face, and right hand. Targeted acupoints: LI 2 Erjian, ST 5 Daying, ST 6 Jiache, ST 7 Xiaguan, SI 19 Tinggong, and BL 13 Feishu.
Pseudo-LASER acupoints therapy
Other intervention
For the pseudo-LASER acupoints therapy, the same procedures and sequence of acupoint application will be followed as in the active treatment. However, the Pointer Pulse device (GMT2000 s.r.l., Italy) will be deactivated to emit no therapeutic laser light while maintaining visual and audio cues to mimic real stimulation. The device will appear active to ensure blinding. Sessions will be conducted once weekly for five weeks, applying the probe to the same bilateral acupoints in the following order: left hand, left face, trunk, right face, and right hand. The targeted points will be LI 2 Erjian, ST 5 Daying, ST 6 Jiache, ST 7 Xiaguan, SI 19 Tinggong, and BL 13 Feishu.

Treatment groups

54 Participants

are divided into 2 treatment groups

Group A: LASER acupoints therapy + Medical treatmentExperimental treatment 2 interventions

Group B: Pseudo-LASER acupoints therapy + Medical treatmentPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Xerostomia Inventory score

Participants will complete the Xerostomia Inventory (XI) questionnaire, a validated tool measuring the subjective burden of dry mouth. It consists of 11 items covering symptoms such as dryness of the mouth, lips, eyes, nose, and face, difficulty with dry foods, sipping liquids, sucking sweets, and nighttime thirst. Responses are rated on a 5-point Likert scale from Never (1) to Very Often (5). Total scores are converted to a 0-10 scale, where 0 represents no burden and 10 indicates an excruciating burden. The questionnaire will be administered at baseline and post-treatment.

Time frame

4 weeks

Secondary outcomes

Stimulated salivary flow rate (SSFR) by Sialometry

Sialometry tests will be used to assess salivary flow. Normal stimulated flow ranges from 1.5-2.0 mL/min, and unstimulated flow from 0.3-0.4 mL/min. Hyposalivation will be diagnosed if stimulated flow is below 0.5-0.7 mL/min or unstimulated flow is under 0.1 mL/min. For unstimulated sialometry, patients will be instructed to expel saliva passively into a glass every minute for 6 minutes without swallowing. For stimulated sialometry, patients will consume something sweet and collect saliva every minute for 6 minutes.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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