Assessing Manual Acupuncture's Impact on Mucositis From Nasopharynx Cancer Radiotherapy: A Visual Analogue Scale (VAS) and Quality of Life Study

University of Indonesia (UI)

Status: Not yet enrolling

Conditions: Nasopharyngeal Carcinoma; Cancer; Mucositis

Treatments: Procedure: Sham Acupuncture; Procedure: Verum Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06472024

24-05-0717

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 19 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Verum Acupuncture

Experimental group

Description:

The verum acupuncture group will receive actual acupuncture therapy 2 times per week for 3 weeks

Treatment:

Procedure: Verum Acupuncture

Sham Acupuncture

Sham Comparator group

Description:

The Sham acupuncture group will receive Sham acupuncture therapy 2 times per week for 3 weeks

Treatment:

Procedure: Sham Acupuncture