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

NCT07029854 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005539
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Xerostomia Following Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (1)

• Stimulated salivary flow rate (SSFR) by Sialometry

  4 weeks

Study Arms (2)

LASER acupoints therapy + Medical treatment

EXPERIMENTAL

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.

Other: Medical treatment; Other: LASER acupoints therapy

Pseudo-LASER acupoints therapy + Medical treatment

PLACEBO COMPARATOR

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).

Other: Medical treatment; Other: Pseudo-LASER acupoints therapy

Interventions

Medical treatment OTHER

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

LASER acupoints therapy + Medical treatment; Pseudo-LASER acupoints therapy + Medical treatment

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.

LASER acupoints therapy + Medical treatment

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.

Pseudo-LASER acupoints therapy + Medical treatment

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El Hussein university Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Amal Mohamed Abd El Baky, PhD

  Professor, Cairo university

  STUDY CHAIR

• Adel Mahmoud Attia, PhD

  Lecturer, Zagazig university

  STUDY DIRECTOR

• Doaa Atef Aly, PhD

  Lecturer, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Nehal Gamal Ebrahim Elwerish, B.Sc

CONTACT

+20 105 033 3378; nehalgamalelwersh@gmail.com

Doaa Atef Aly, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: June 18, 2025
• Primary Completion: August 18, 2025
• Study Completion: August 31, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

EG (1)