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

NCT ID: NCT07075809

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2025-12-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Investigation Group

The laser acupuncture

Group Type: EXPERIMENTAL

The laser acupuncture

Intervention Type: 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.

Control Group

The sham laser acupuncture

Group Type: SHAM_COMPARATOR

Sham Laser acupuncture

Intervention Type: 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.

Interventions

The laser acupuncture

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.

Intervention Type: DEVICE

Sham Laser acupuncture

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Resti Victoria Fanggidae

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KPEK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

The Health Research Ethics Commitee of Faculty of Medicine

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

25-06-0942

Identifier Type: -

Identifier Source: org_study_id