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

NCT07044414 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-31

No results posted yet for this study

Summary

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

Conditions

  • Head and Neck Neoplasms

Interventions

DEVICE

Manual Acupuncture

Manual acupuncture is administered at bilateral ST36 Zusanli, SP6 Sanyinjiao, and midline points CV4 Guanyuan and CV6 Qihai using sterile, single-use 0.25 × 25 mm acupuncture needles. The insertion depth follows standard clinical practice and safety guidelines, with twirling stimulation performed at minutes 0 and 10. Each session lasts approximately 20 minutes and is conducted three times per week for a total of 21 sessions. Participants continue to receive their standard chemoradiotherapy for head and neck cancer.

DEVICE

Sham Manual Acupuncture

Sham Manual acupuncture uses Park sham needles with telescopic tips that do not penetrate the skin, applied at the same acupoints (ST36, SP6, CV4, CV6) with identical procedure and appearance to mimic real acupuncture. Adhesive bases are used to fix the sham needles. Stimulation is mimicked at minutes 0 and 10. Sessions last the same duration and frequency as the intervention group. Participants also continue their standard chemoradiotherapy.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • KPEK FKUI-RSCM · The Health Research Ethics Commitee of Faculty Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-12-12
Completion
2025-12-12

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07044414 on ClinicalTrials.gov