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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigation Group | Experimental | The laser acupuncture |
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| Control Group | Sham Comparator | The sham laser acupuncture |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The laser acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Leukocyte Count | Leukocyte count is the measure of the number of white blood cells (leukocytes) present in the blood | 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. | 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. | 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. | Before therapy, between 7-14 day after chemoterapy |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | The Health Research Ethics Commitee of Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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the laser acupuncture will be designated as the investigation group while the sham laser acupuncture will be designated as the control group
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The participants and the outcome assessors will be blinded to group allocation
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| Sham Laser acupuncture | Device | 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. |
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