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

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

NCT ID: NCT06472024

Condition: Cancer
Nasopharyngeal Carcinoma
Mucositis

Conditions: Official terms:
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Mucositis

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Verum Acupuncture
Description: Acupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect.
Arm group label: Verum Acupuncture

Intervention type: Procedure
Intervention name: Sham Acupuncture
Description: Sham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points
Arm group label: Sham Acupuncture

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

Criteria for 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

Gender: All

Minimum age: 19 Years

Maximum age: 59 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: July 2024

Completion date: September 2024

Lead sponsor:
Agency: Indonesia University
Agency class: Other

Source: Indonesia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06472024