NCT07029854

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Xerostomia Following Radiotherapy

Interventions

Type	Name	Description
OTHER	Medical treatment	They will receive oral chemotherapy, based on the cancer stage, and will also undergo radiotherapy.
OTHER	LASER acupoints therapy	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.
OTHER	Pseudo-LASER acupoints therapy	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.

Timeline

• Start date: 2025-06-18
• Primary completion: 2025-08-18
• Completion: 2025-08-31
• First posted: 2025-06-19
• Last updated: 2025-06-19

Locations

1 site across 1 country: Egypt