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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-31

Study Completion Date

2024-09-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Cancer Nasopharyngeal Carcinoma Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Verum Acupuncture

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

Group Type EXPERIMENTAL

Verum Acupuncture

Intervention Type PROCEDURE

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

Sham Acupuncture

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

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type PROCEDURE

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

Interventions

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Verum Acupuncture

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

Intervention Type PROCEDURE

Sham Acupuncture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes