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

NCT ID: NCT07029854

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2025-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LASER acupoints therapy + Medical treatment

This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive LASER acupoints therapy (3 times per week, for 4 weeks), plus medical treatment.

Group Type: EXPERIMENTAL

Medical treatment

Intervention Type: OTHER

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

LASER acupoints therapy

Intervention Type: 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 + Medical treatment

This group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive pseudo-LASER acupoints therapy plus medical treatment (for 4 weeks).

Group Type: PLACEBO_COMPARATOR

Medical treatment

Intervention Type: OTHER

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

Pseudo-LASER acupoints therapy

Intervention Type: 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.

Interventions

Medical treatment

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Gamal Ebrahim Elwerish

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Mohamed Abd El Baky, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Adel Mahmoud Attia, PhD

Role: STUDY_DIRECTOR

Lecturer, Zagazig university

Doaa Atef Aly, PhD

Role: STUDY_DIRECTOR

Lecturer, Cairo university

Locations

El Hussein university Hospital

Cairo, , Egypt

Countries

Egypt

Central Contacts

Nehal Gamal Ebrahim Elwerish, B.Sc

Role: CONTACT

nehalgamalelwersh@gmail.com

+20 105 033 3378

Doaa Atef Aly, PhD

Role: CONTACT

Facility Contacts

Nehal Gamal Ebrahim Elwerish, B.Sc

Role: primary

nehalgamalelwersh@gmail.com

+20 105 033 3378

Other Identifiers

P.T.REC/012/005539

Identifier Type: -

Identifier Source: org_study_id