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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Manual Acupuncture |
|
| Control group | Sham Comparator | Sham Manual Acupuncture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | The Health Research Ethics Commitee of Faculty Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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The intervention group will receive Manual Acupuncture, while the control group will receive sham Manual Acupuncture
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Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
|
| 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. |
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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 |
| Time Frame: Baseline, Week 7 |