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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-59
SponsorIndonesia University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Verum Acupuncture

    Procedure/Surgery

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

  • Sham Acupuncture

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Verum AcupunctureExperimental treatment 1 intervention
Group B: Sham AcupunctureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.
2

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.

Time frame
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

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: