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

University of Indonesia (UI)

Status: Completed

Conditions: Leucopenia Induced Chemoteraphy Adult

Treatments: Device: Sham Laser acupuncture; Device: The laser acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07075809

25-06-0942

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Investigation Group

Experimental group

Description:

The laser acupuncture

Treatment:

Device: The laser acupuncture

Control Group

Sham Comparator group

Description:

The sham laser acupuncture

Treatment:

Device: Sham Laser acupuncture