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NCT Number: NCT07029854

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Xerostomia Following Radiotherapy

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The current diagnosis is based on the primary complaint reported by the patient. A previous study found that patients with cancer reported different degrees of dry mouth, reduced drinking and eating and waking up at night due to dry mouth and that the risk of progression to oral ulcers was higher among this patient population and could significantly affect the quality of life.

Acupuncture may be effective in treating xerostomia and also, acupuncture has been shown to increase salivary flow in healthy volunteers.

As xerostomia gradually comes to the attention of the wider medical community, clinical evidence is slowly starting to amass to help assess which treatments are most effective, but more research is needed. Furthermore, there is a lack in the quantitative knowledge and information in the published studies about benefits of acupuncture on xerostomia during chemo radiation therapy. So, this study is designed to outline the therapeutic efficacy of acupuncture on xerostomia during chemo radiation therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • They Were taking heparin or warfarin.
  • They had contraindications for the use of acupuncture at any acupoints.
  • They had history of cerebrovascular accident or spinal cord injury.
  • They had taken any drug or herbal medicine in the past 30 days that could affect salivary function.
  • They were planning to, or ended up taking such a substance during the study.
  • Any therapy that may affect treatment.

Treatment and study plan

Medical treatment

Other

They will receive oral chemotherapy, based on the cancer stage, and will also undergo radiotherapy.

LASER acupoints therapy

Other

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

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.

Primary outcomes

  1. Xerostomia Inventory score

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Stimulated salivary flow rate (SSFR) by Sialometry

    Time frame: 4 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa Atef Aly, PhD

CONTACT

Nehal Gamal Ebrahim Elwerish, B.Sc

CONTACT

[email protected]

+20 105 033 3378

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Jun 19, 2025

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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