Head and Neck CancerNCT07029854
Laser Acupoints Stimulation on Xerostomia Related Chemoradiotherapy for Head and Neck Cancer Patients
A study testing Medical treatment, LASER acupoints therapy and Pseudo-LASER acupoints therapy in people with Head and Neck Cancer and Xerostomia Following Radiotherapy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Head and Neck Cancer, Xerostomia Following Radiotherapy
- What is being tested?
- Medical treatment, LASER acupoints therapy and Pseudo-LASER acupoints therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Doaa Atef Aly, PhD contact
Egypt1 site
El Hussein university Hospital
Cairo
Nehal Gamal Ebrahim Elwerish, B.Sc, +20 105 033 3378, nehalgamalelwersh@gmail.com
About this study
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.
Read the 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.
- Being tested
- Medical treatment, LASER acupoints therapy, Pseudo-LASER acupoints therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentOther
They will receive oral chemotherapy, based on the cancer stage, and will also undergo radiotherapy.
LASER acupoints therapyOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Medical treatment; Other: Pseudo-LASER acupoints therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (1)
Stimulated salivary flow rate (SSFR) by Sialometry
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start18 Jun 2025 (estimated)
- Primary completion18 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Gamal Ebrahim Elwerish, Cairo University
- Investigators
- Amal Mohamed Abd El Baky, PhD, Study chair, Professor, Cairo universityAdel Mahmoud Attia, PhD, Study director, Lecturer, Zagazig universityDoaa Atef Aly, PhD, Study director, Lecturer, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029854
- Sponsor's protocol ID
- P.T.REC/012/005539
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupoints Stimulation on Xerostomia Related Chemoradiotherapy for Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT07029854
- Acronym / sponsor ID
- P.T.REC/012/005539
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jun 2025 (estimated)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LASER acupoints therapy + Medical treatment | Experimental | Other: Medical treatment, Other: LASER acupoints therapyThis 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. |
| Pseudo-LASER acupoints therapy + Medical treatment | Placebo comparator | Other: Medical treatment, Other: Pseudo-LASER acupoints therapyThis group will include twenty-seven patients suffering xerostomia (dryness of mouth), who will receive pseudo-LASER acupoints therapy plus medical treatment (for 4 weeks). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical treatmentThey will receive oral chemotherapy, based on the cancer stage, and will also undergo radiotherapy. | Other | LASER acupoints therapy + Medical treatment, Pseudo-LASER acupoints therapy + Medical treatment |
| LASER acupoints therapyLASER 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 | LASER acupoints therapy + Medical treatment |
| Pseudo-LASER acupoints therapyFor 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. | Other | Pseudo-LASER acupoints therapy + Medical treatment |
Primary outcome
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.
1 secondary outcome
Stimulated salivary flow rate (SSFR) by Sialometry
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Doaa Atef Aly, PhD contact
Amal Mohamed Abd El Baky, PhD study chair
Professor, Cairo university
Adel Mahmoud Attia, PhD study director
Lecturer, Zagazig university
Doaa Atef Aly, PhD study director
Lecturer, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment, LASER acupoints therapy and Pseudo-LASER acupoints therapy in people with Head and Neck Cancer and Xerostomia Following Radiotherapy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nehal Gamal Ebrahim Elwerish, B.Sc (+20 105 033 3378, nehalgamalelwersh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Xerostomia Inventory score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.