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

NCT07044414 | Completed

• 1 other identifier: 25-06-0859
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Leukocyte Count

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

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

• Absolute Neutrophil Count (ANC)

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

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

Secondary Outcomes (2)

• Visual Analogue Scale - Fatigue (VAS-F)

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

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

  Time Frame: Baseline, Week 7

Study Arms (2)

Intervention Group

EXPERIMENTAL

Manual Acupuncture

Device: Manual Acupuncture

Control group

SHAM COMPARATOR

Sham Manual Acupuncture

Device: Sham Manual Acupuncture

Interventions

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.

Intervention Group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee of Faculty Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: The intervention group will receive Manual Acupuncture, while the control group will receive sham Manual Acupuncture

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: September 1, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-08

Locations

ID (1)