Head and Neck NeoplasmsNCT07044414
Effectiveness of Manual Acupuncture for Head and Neck Cancer Patients Undergoing Chemoradiation
A study testing Manual Acupuncture in people with Head and Neck Neoplasms, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Manual Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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:
Read more
- 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
- Being tested
- Manual Acupuncture, Sham Manual Acupuncture
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual AcupunctureDevice
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 AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Manual Acupuncture Receives: Device: Manual Acupuncture |
| Control group | Sham comparator | Sham Manual Acupuncture Receives: Device: Sham Manual Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocyte Count
Leukocyte count (cells/µL) will be measured through laboratory tests to evaluate changes in white blood cell levels.
Measured: 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.
Measured: 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)
Cancer-related fatigue will be assessed using the VAS-F scale ranging from 0 (no fatigue) to 10 (worst possible fatigue)
Measured: 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)
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
Measured: Time Frame: Baseline, Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Sep 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention group will receive Manual Acupuncture, while the control group will receive sham Manual Acupuncture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thia Wanudyo Hutami, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee of Faculty Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044414
- Sponsor's protocol ID
- 25-06-0859
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07044414
- Acronym / sponsor ID
- 25-06-0859
- Conditions
- Head and Neck Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will receive Manual Acupuncture, while the control group will receive sham Manual Acupuncture
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Manual AcupunctureManual Acupuncture |
| Control group | Sham comparator | Device: Sham Manual AcupunctureSham Manual Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual AcupunctureManual 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 | Intervention Group |
| Sham Manual AcupunctureSham 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. | Device | Control group |
Primary outcome
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.
2 secondary outcomes
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
EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)
Time frame: Time Frame: Baseline, Week 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee of Faculty Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Acupuncture in people with Head and Neck Neoplasms, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukocyte Count (time frame: Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 , Week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.