Clinical trial NCT06472024: Assessing Manual Acupuncture's Impact on Mucositis From Nasopharynx Cancer Radiotherapy: A Visual Analogue Scale (VAS) and Quality of Life Study
Official title: Effects Of Manual Acupuncture On Mucositis Due To Radiotherapy For Nasopharynx Cancer On Visual Analogue Scale (Vas) Score And Quality Of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Nasopharyngeal Carcinoma
Mucositis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This is a clinical trial study to evaluate the role of acupuncture in pain relief and improving the quality of life of nasopharyngeal cancer patients with post-radiotherapy mucositis. Participants were 30 men/females with mucositis in post-radiotherapy nasopharyngeal cancer aged 19-59 years. They will be divided into 2 groups: (1) verum acupuncture and (2) sham acupuncture. Acupuncture is scheduled 2 times per week for 3 weeks. Research assessment on pain scale and improvement in quality of life

Eligibility criteria: Inclusion Criteria:

* 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.
* Willing to participate in the research until completion by signing an informed consent.

Exclusion Criteria:

* 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.
* Patients with blood clotting disorders; Platelets \<50,000/μL, Absolute Neutrophil Count (ANC) \<1000/mm3, patients undergoing anticoagulant therapy with International Normalized Ratio (INR) \>2.47

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.
measure: European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35)
timeFrame: Monitored before and after intervention. After the intervention; Results will be measured at week 3 after intervention and results will be measured at week 4 without intervention.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: