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

Effects Of Manual Acupuncture On Mucositis Due To Radiotherapy For Nasopharynx Cancer On Visual Analogue Scale (Vas) Score And Quality Of Life

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Nasopharyngeal Carcinoma; Mucositis
• Intervention / Treatment: Procedure: Verum Acupuncture; Procedure: Sham Acupuncture

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imelda Dimara, MD; Phone Number: +6282319769944; Email: imeldadimara560@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum Acupuncture; The verum acupuncture group will receive actual acupuncture therapy 2 times per week for 3 weeks	Procedure: Verum Acupuncture; Acupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect.
Sham Comparator: Sham Acupuncture; The Sham acupuncture group will receive Sham acupuncture therapy 2 times per week for 3 weeks	Procedure: Sham Acupuncture; Sham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.
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.	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.

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI-RSCM, The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Diseases; Gastroenteritis; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Mucositis
• Other Study ID Numbers: 24-05-0717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No