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

NCT07029854 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Amal Mohamed Abd El Baky, PhD · Professor, Cairo university

  • Adel Mahmoud Attia, PhD · Lecturer, Zagazig university

  • Doaa Atef Aly, PhD · Lecturer, Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-18
Primary Completion
2025-08-18
Completion
2025-08-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07029854 on ClinicalTrials.gov