Effectiveness of Manual Acupuncture for Head and Neck Cancer Patients Undergoing Chemoradiation

University of Indonesia (UI)

Status: Completed

Conditions: Head and Neck Neoplasms

Treatments: Device: Sham Manual Acupuncture; Device: Manual Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07044414

25-06-0859

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Manual Acupuncture

Treatment:

Device: Manual Acupuncture

Control group

Sham Comparator group

Description:

Sham Manual Acupuncture

Treatment:

Device: Sham Manual Acupuncture