Skip to main content
OpenTrials
Completed

NCT Number: NCT07044414

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual acupuncture

Device

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.

Sham Manual Acupuncture

Device

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.

Primary outcomes

  1. Leukocyte Count

    Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7

    Leukocyte count (cells/µL) will be measured through laboratory tests to evaluate changes in white blood cell levels.

  2. Absolute Neutrophil Count (ANC)

    Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7

    ANC (cells/µL) will be measured to assess neutrophil recovery and myelosuppression status.

Secondary outcomes

  1. Visual Analogue Scale - Fatigue (VAS-F)

    Time frame: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7

    Cancer-related fatigue will be assessed using the VAS-F scale ranging from 0 (no fatigue) to 10 (worst possible fatigue)

  2. EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)

    Time frame: Time Frame: Baseline, Week 7

    Quality of life will be measured using the EORTC QLQ-C30, a validated questionnaire with multiple domains (physical, emotional, role, social, cognitive function, and symptoms). Higher scores in global health reflect better QoL, while higher symptom scores indicate worse outcomes

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effectiveness of Manual Acupuncture as an Adjuvant Therapy for Head and Neck Cancer Patients Undergoing Chemoradiation at the Radiation Oncology Polyclinic of RSUPN DR. Cipto Mangunkusumo

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.