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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Absolute Neutrophil Count (ANC)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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.
Arms & Interventions
Intervention Group
Manual Acupuncture
Intervention: Manual Acupuncture (Device)
Control group
Sham Manual Acupuncture
Intervention: Sham Manual Acupuncture (Device)
Outcomes
Primary Outcomes
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.
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.
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.
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
- Visual Analogue Scale - Fatigue (VAS-F)(Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7)
- 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)
Investigators
Thia Wanudyo Hutami
Medical Doctor
Indonesia University