Overview
The goal of this clinical trial is to assess whether manual acupuncture (MA) is more effective than sham acupuncture in improving leukocyte count and reducing cancer-related fatigue (CRF) in head and neck cancer (HNC) patients undergoing chemoradiation therapy (CRT).
The main questions it aims to answer are:
- Does MA, compared to sham acupuncture, increase leukocyte and absolute neutrophil count (ANC) during CRT?
- Does MA, compared to sham acupuncture, reduce the severity of CRF as measured by the Visual Analogue Scale-Fatigue (VAS-F)?
- Does MA, compared to sham acupuncture, improve quality of life as measured by the EORTC QLQ-C30 questionnaire?
Participants will:
- Be adult patients with head and neck cancer who have completed induction chemotherapy and are undergoing CRT
- Be screened based on inclusion and exclusion criteria, including normal INR and platelet count above 25,000/mm³
- Be randomly assigned to either the MA group or sham group using Park sham needle
- Receive acupuncture at points ST36, SP6, CV4, and CV6 three times per week for seven sessions (total 21 sessions)
- Be evaluated for leukocyte count, ANC, fatigue (VAS-F), and quality of life (EORTC QLQ-C30) at baseline and at weekly intervals during therapy
Eligibility
Inclusion Criteria:
- Subjects diagnosed with head and neck cancer (HNC) based on histopathological examination, who have completed induction chemotherapy and are scheduled to undergo radiotherapy.
- Subjects aged ≥18 years.
- Subjects willing to participate in this study and provide written informed consent.
- Subjects with a Mini Mental State Examination (MMSE) score ≥24.
- Subjects with oxygen saturation ≥95% on room air.
- Subjects with stage III or IVA cancer.
- Subjects receiving a radiation dose of 66-70 Gy.
Exclusion Criteria:
- Subjects with severe comorbidities such as chronic kidney failure, metastatic liver cirrhosis, or heart disease.
- Subjects currently undergoing other therapies that may affect leukocyte counts, such as immunomodulatory therapy or high-dose corticosteroid use.
- Subjects who are still smoking or consuming alcohol.
- Subjects with blood clotting disorders or those currently taking anticoagulants, confirmed by laboratory results: neutrophils <1,000/mm³, platelets <25,000/mm³, INR >2.0, or partial thromboplastin time >20 seconds.
- Pregnant or breastfeeding women.