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

Not Applicable

Not yet recruiting

• Conditions: Myelosuppression Adult

• Registration Number: NCT07075809
• Lead Sponsor: Indonesia University

Brief Summary

The goal of this clinical trial is to evaluate if laserpuncture (laser acupuncture) can reduce myelosuppression 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 myelosuppression?

* 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 laserpunktur 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Study Start: 2025-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Leukocyte Count	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	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.
EORTC QLQ C30 questionnaire	Before therapy, between 7-14 day after chemoterapy	Self-reported questionnaire to assess the quality of life of cancer patients.
EORTC QLQ H&N35 questionnaire	Before therapy, between 7-14 day after chemoterapy	Self-reported questionnaire to assess quality of life specific to patients with head and neck cancer.

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia