About this trial
The goal of this clinical trial is to learn if acupuncture can play a role in reducing pain and improving the quality of life of post-radiotherapy nasopharyngeal cancer mucositis patients. The main questions it aims to answer are:
\- Do manual acupuncture and medication therapy affect pain intensity as measured by the visual analogue scale (VAS) in patients with oral mucositis compared with sham manual acupuncture and medication?
Participants will receive acupuncture therapy 2 times a week for 3 weeks
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects who have been proven by anatomical pathology examination to have a diagnosis of Nasopharyngeal Cancer.
Subjects with adult Nasopharyngeal Cancer aged 19 years - 59 years.
Nasopharyngeal Cancer Patients, who underwent bilateral Head and Neck radiotherapy.
Patients diagnosed with mucositis.
Disqualifiers
Nasopharyngeal Cancer patients who have distant metastases (based on the Tumor Node Metastasis (TNM) classification with the presence of metastases (M1)).
Subjects who still smoke and consume alcohol to date.
Patients have contraindications for manual acupuncture, namely the use of anti-coagulant drugs, the presence of infection or wounds at the puncture site, emergency conditions, and pregnancy.
There is a history of allergy to stainless steel materials.
Trial design
Parallel
Treatments tested in this trial
Verum Acupuncture
Procedure/SurgeryAcupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect.
Sham Acupuncture
Procedure/SurgerySham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points
Treatment groups
Trial outcomes
Primary outcomes
Visual Analogue Scale
VAS is used to assess pain complaints on a scale of 1-10. The VAS scale consists of: mild pain scale 1-3, moderate pain scale 4-6 and severe pain scale 7-10
European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35)
The EORTC QLQ-H\&N35 is a questionnaire designed to assess the health-related quality of life in patients with head and neck cancer. It consists of 35 questions covering various aspects such as pain, swallowing, speech, social eating, and emotional functioning. Each question is scored on a scale from 1 to 4, with 1 representing "not at all" and 4 representing "very much". To calculate a score for each domain, the individual item scores are averaged. Higher scores indicate more severe symptoms or poorer quality of life in that domain. Additionally, there are specific guidelines provided by the European Organization for Research and Treatment of Cancer (EORTC) for scoring and interpreting the results, with a minimum and maximum scale of 0-33: mild, 34-66: moderate, 67-100: severe.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: