The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia in Head and Neck Cancer Patients

NCT07075809 | Completed

• 1 other identifier: 25-06-0942
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Leucopenia Induced Chemoteraphy Adult

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Investigation Group

EXPERIMENTAL

The laser acupuncture

Device: The laser acupuncture

Control Group

SHAM COMPARATOR

The sham laser acupuncture

Device: Sham Laser acupuncture

Interventions

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.

Investigation Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee of Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome assessors will be blinded to group allocation
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: the laser acupuncture will be designated as the investigation group while the sham laser acupuncture will be designated as the control group

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

ID (1)