Leucopenia Induced Chemoteraphy AdultNCT07075809
The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia in Head and Neck Cancer Patients
A study testing The laser acupuncture in people with Leucopenia Induced Chemoteraphy Adult, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate if laserpuncture (laser acupuncture) can reduce leucopenia caused by chemotherapy and improve the quality of life in patients with head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Leucopenia Induced Chemoteraphy Adult
- What is being tested?
- The laser acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients with head and neck cancer, aged 18-60 years.
- Head and neck cancer patients diagnosed through histopathological examination, with cancer stages II to IV.
- Head and neck cancer patients undergoing chemotherapy with platinum-based chemotherapy drugs combined with 5-Fluorouracil, in the first treatment cycle.
- Leukocyte count greater than 5000/mm³.
- Patients who have signed informed consent and are willing to participate in the study until completion.
- Normal Mini-Mental State Examination (MMSE) score (27-31).
Who cannot join
- Patients with cancer lesions, ulcers, acute dermatitis, or exacerbation of chronic skin diseases at the selected acupuncture points.
- Patients with deformities or anatomical abnormalities of the ear.
- Patients with fever (body temperature >38ºC).
- Patients with hemodynamic instability (patient vital signs outside the normal limits. Normal vital signs include axillary temperature of 36.5 - 37.5ºC, systolic blood pressure 102 - 131 mmHg, diastolic blood pressure 61 - 83 mmHg, pulse rate 60 - 100 beats/minute. Unstable if respiratory rate is above 25 breaths/minute or SpO2 < 90%).
- Patients with a history of allergy to laser irradiation (skin hypersensitivity due to exposure to specific light).
- Patients with a history of uncontrolled seizures or epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia and Quality of Life in Head and Neck Cancer Patients
The goal of this clinical trial is to evaluate if laserpuncture (laser acupuncture) can reduce leucopenia caused by chemotherapy and improve the quality of life in patients with head and neck cancer. The main questions it aims to answer are:
- Does laserpuncture reduce the incidence of chemotherapy-induced Leucopenia ?
- Does laserpuncture improve quality of life in these patients?
Read more
Researchers will compare patients receiving laserpuncture therapy to a control group receiving sham laserpuncture to see if the intervention has a beneficial effect.
Participants will:
- Undergo six sessions of laserpunktur or sham laserpuncture during chemotherapy
- Have leukocyte counts and absolute neutrophil counts measured before and 7-14 days after chemotherapy
- Complete quality of life assessments using EORTC QLQ-C30 and EORTC QLQ-H\&N35 questionnaires
- Conditions
- Leucopenia Induced Chemoteraphy Adult
- Being tested
- The laser acupuncture, Sham Laser acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The laser acupunctureDevice
The intervention group in this study receives laser acupuncture therapy using a laser Micropad GL2+ device with an infrared wavelength of 880 nm. The laser acupuncture is applied to specific acupuncture points, namely GV14, LI4, ST36, and SP6 on the body, as well as ear points including MA-TF1 Shenmen, MA-SC5 Liver, MA-IC3 Endocrine, MA-IC8 Spleen, and MA-SC6 Kidney. Treatment is administered once daily for a total of six sessions during the chemotherapy treatment period.
Sham Laser acupunctureDevice
The Control group in this study receives sham laser acupuncture therapy using a laser Micropad GL2+ device with deactivation mode. The sham laser acupuncture is applied to specific acupuncture points, namely GV14, LI4, ST36, and SP6 on the body, as well as ear points including MA-TF1 Shenmen, MA-SC5 Liver, MA-IC3 Endocrine, MA-IC8 Spleen, and MA-SC6 Kidney. Treatment is administered once daily for a total of six sessions during the chemotherapy treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Investigation Group | Experimental | The laser acupuncture Receives: Device: The laser acupuncture |
| Control Group | Sham comparator | The sham laser acupuncture Receives: Device: Sham Laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte Count
Leukocyte count is the measure of the number of white blood cells (leukocytes) present in the blood
Measured: Before therapy, between 7-14 day after chemoterapy
Absolute Neutrophil Count
The Absolute Neutrophil Count (ANC) is a laboratory measure of the number of neutrophils, a type of white blood cell that plays a critical role in fighting infection, present in the blood.
Measured: Before therapy, between 7-14 day after chemoterapy
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 questionnaire
Self-reported questionnaire to assess the quality of life of cancer patients.
Measured: Before therapy, between 7-14 day after chemoterapy
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Heand &Neck 35 questionnaire
Self-reported questionnaire to assess quality of life specific to patients with head and neck cancer.
Measured: Before therapy, between 7-14 day after chemoterapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Oct 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leucopenia Induced Chemoteraphy AdultStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- the laser acupuncture will be designated as the investigation group while the sham laser acupuncture will be designated as the control group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Resti Victoria Fanggidae, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee of Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075809
- Sponsor's protocol ID
- 25-06-0942
- Status last verified
- Dec 2025
- First submitted
- 10 Jul 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia and Quality of Life in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT07075809
- Acronym / sponsor ID
- 25-06-0942
- Conditions
- Leucopenia Induced Chemoteraphy Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 20 Jul 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 goal of this clinical trial is to evaluate if laserpuncture (laser acupuncture) can reduce leucopenia caused by chemotherapy and improve the quality of life in patients with head and neck cancer. The main questions it aims to answer are:
- Does laserpuncture reduce the incidence of chemotherapy-induced Leucopenia ?
- Does laserpuncture improve quality of life in these patients?
Researchers will compare patients receiving laserpuncture therapy to a control group receiving sham laserpuncture to see if the intervention has a beneficial effect.
Participants will:
- Undergo six sessions of laserpunktur or sham laserpuncture during chemotherapy
- Have leukocyte counts and absolute neutrophil counts measured before and 7-14 days after chemotherapy
- Complete quality of life assessments using EORTC QLQ-C30 and EORTC QLQ-H\&N35 questionnaires
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- the laser acupuncture will be designated as the investigation group while the sham laser acupuncture will be designated as the control group
| Arm | Type | Receives |
|---|---|---|
| Investigation Group | Experimental | Device: The laser acupunctureThe laser acupuncture |
| Control Group | Sham comparator | Device: Sham Laser acupunctureThe sham laser acupuncture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female patients with head and neck cancer, aged 18-60 years.
- Head and neck cancer patients diagnosed through histopathological examination, with cancer stages II to IV.
- Head and neck cancer patients undergoing chemotherapy with platinum-based chemotherapy drugs combined with 5-Fluorouracil, in the first treatment cycle.
- Leukocyte count greater than 5000/mm³.
- Patients who have signed informed consent and are willing to participate in the study until completion.
Key exclusion criteria (6 listed)
- Patients with cancer lesions, ulcers, acute dermatitis, or exacerbation of chronic skin diseases at the selected acupuncture points.
- Patients with deformities or anatomical abnormalities of the ear.
- Patients with fever (body temperature >38ºC).
- Patients with hemodynamic instability (patient vital signs outside the normal limits. Normal vital signs include axillary temperature of 36.5 - 37.5ºC, systolic blood pressure 102 - 131 mmHg, diastolic blood pressure 61 - 83 mmHg, pulse rate 60 - 100 beats/minute. Unstable if respiratory rate is above 25 breaths/minute or SpO2 < 90%).
- Patients with a history of allergy to laser irradiation (skin hypersensitivity due to exposure to specific light).
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 |
|---|---|---|
| The laser acupunctureThe intervention group in this study receives laser acupuncture therapy using a laser Micropad GL2+ device with an infrared wavelength of 880 nm. The laser acupuncture is applied to specific acupuncture points, namely GV14, LI4, ST36, and SP6 on the body, as well as ear points including MA-TF1 Shenmen, MA-SC5 Liver, MA-IC3 Endocrine, MA-IC8 Spleen, and MA-SC6 Kidney. Treatment is administered once daily for a total of six sessions during the chemotherapy treatment period. | Device | Investigation Group |
| Sham Laser acupunctureThe Control group in this study receives sham laser acupuncture therapy using a laser Micropad GL2+ device with deactivation mode. The sham laser acupuncture is applied to specific acupuncture points, namely GV14, LI4, ST36, and SP6 on the body, as well as ear points including MA-TF1 Shenmen, MA-SC5 Liver, MA-IC3 Endocrine, MA-IC8 Spleen, and MA-SC6 Kidney. Treatment is administered once daily for a total of six sessions during the chemotherapy treatment period. | Device | Control Group |
Primary outcome
Leukocyte Count
Time frame: Before therapy, between 7-14 day after chemoterapy
Leukocyte count is the measure of the number of white blood cells (leukocytes) present in the blood
Absolute Neutrophil Count
Time frame: Before therapy, between 7-14 day after chemoterapy
The Absolute Neutrophil Count (ANC) is a laboratory measure of the number of neutrophils, a type of white blood cell that plays a critical role in fighting infection, present in the blood.
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 questionnaire
Time frame: Before therapy, between 7-14 day after chemoterapy
Self-reported questionnaire to assess the quality of life of cancer patients.
European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Heand &Neck 35 questionnaire
Time frame: Before therapy, between 7-14 day after chemoterapy
Self-reported questionnaire to assess quality of life specific to patients with head and neck cancer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee of Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The laser acupuncture in people with Leucopenia Induced Chemoteraphy Adult, run by Universitas Indonesia at 1 site in Indonesia.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jan 2026. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte Count (time frame: Before therapy, between 7-14 day after chemoterapy). The study lists 4 primary outcomes in all. 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 5 Jan 2026.