Clinical trial · Interventional
The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia in Head and Neck Cancer Patients
The Effectiveness of Laserpuncture on Chemotherapy-induced Leucopenia and Quality of Life in Head and Neck Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leucopenia Induced Chemoteraphy Adult | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham Laser acupuncture | Device | — | UNRESOLVED |
| The laser acupuncture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Investigation Group
- description
- The laser acupuncture
- interventionNames
- Device: The laser acupuncture
- type
- SHAM_COMPARATOR
- label
- Control Group
- description
- The sham laser acupuncture
- interventionNames
- Device: Sham Laser acupuncture
Primary outcomes (4)
- measure
- Leukocyte Count
- timeFrame
- Before therapy, between 7-14 day after chemoterapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available