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Not yet recruitingNCT06472024Updated Jun 26, 2024

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

An interventional study of Verum Acupuncture and Sham Acupuncture in Cancer, Nasopharyngeal Carcinoma and Mucositis, sponsored by Indonesia University. Not yet recruiting. Open to participants aged 19 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 59 Years
Sex
All
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Study 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

Read the 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

02

Conditions studied

  • Cancer
  • Nasopharyngeal Carcinoma
  • Mucositis
03

In context

Nasopharyngeal Carcinoma

816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.

This study's planned enrollment of 30 is below the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Verum Acupuncture

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

    Procedure: Verum Acupuncture

  • Sham comparator
    Sham Acupuncture

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

    Procedure: Sham Acupuncture

Interventions

  • ProcedureVerum Acupuncture

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

  • ProcedureSham Acupuncture

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

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What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06472024
Lead sponsor
Indonesia University
Responsible party
Imelda Dimara (Medical Doctor, Indonesia University) — Principal investigator
First posted
Jun 24, 2024
Start date
Jul 2024 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 26, 2024

Study contacts

Imelda Dimara, MD
Contact
imeldadimara560@gmail.com
+6282319769944
KEPK FKUI-RSCM
principal investigator · The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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