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

NCT06472024 | Not Yet Recruiting

• 1 other identifier: 24-05-0717
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cancer; Nasopharyngeal Carcinoma; Mucositis

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Verum Acupuncture

EXPERIMENTAL

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

Procedure: Verum Acupuncture

Sham Acupuncture

SHAM COMPARATOR

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

Procedure: Sham Acupuncture

Interventions

Verum Acupuncture PROCEDURE

Acupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect.

Verum Acupuncture

Sham Acupuncture PROCEDURE

Sham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points

Sham Acupuncture

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Neoplasms; Nasopharyngeal Carcinoma; Mucositis

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases

Study Officials

• KEPK FKUI-RSCM

  The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imelda Dimara, MD

CONTACT

+6282319769944; imeldadimara560@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share