CancerNCT06472024
Assessing Manual Acupuncture's Impact on Mucositis From Nasopharynx Cancer Radiotherapy: A Visual Analogue Scale (VAS) and Quality of Life Study
A study testing Verum Acupuncture in people with Cancer and Nasopharyngeal Carcinoma, run by Universitas Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Nasopharyngeal Carcinoma, Mucositis
- What is being tested?
- Verum Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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
- Conditions
- Cancer, Nasopharyngeal Carcinoma, Mucositis
- Being tested
- Verum Acupuncture, Sham Acupuncture
- Medical subject headings
- Neoplasms, Nasopharyngeal Carcinoma, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum AcupunctureProcedure or surgery
Acupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect.
Sham AcupunctureProcedure or surgery
Sham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points
| Study group | Role | What they receive |
|---|---|---|
| Verum Acupuncture | Experimental | The verum acupuncture group will receive actual acupuncture therapy 2 times per week for 3 weeks Receives: Procedure: Verum Acupuncture |
| Sham Acupuncture | Sham comparator | The Sham acupuncture group will receive Sham acupuncture therapy 2 times per week for 3 weeks Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imelda Dimara, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472024
- Sponsor's protocol ID
- 24-05-0717
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Manual Acupuncture On Mucositis Due To Radiotherapy For Nasopharynx Cancer On Visual Analogue Scale (Vas) Score And Quality Of Life
- ClinicalTrials.gov ID
- NCT06472024
- Acronym / sponsor ID
- 24-05-0717
- Conditions
- Cancer, Nasopharyngeal Carcinoma, Mucositis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Acupuncture | Experimental | Procedure: Verum AcupunctureThe verum acupuncture group will receive actual acupuncture therapy 2 times per week for 3 weeks |
| Sham Acupuncture | Sham comparator | Procedure: Sham AcupunctureThe Sham acupuncture group will receive Sham acupuncture therapy 2 times per week for 3 weeks |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum AcupunctureAcupuncture therapy uses filiform needles at a perpendicular angle at acupuncture points to produce a therapeutic effect. | Procedure or surgery | Verum Acupuncture |
| Sham AcupunctureSham Acupuncture therapy uses filiform needles but is only attached with tape to acupuncture points | Procedure or surgery | Sham Acupuncture |
Primary outcome
Visual Analogue Scale
Time frame: Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.
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
European Organization For Research And Treatment Of Cancer Head and Neck Cancer Quality of Life Questionnaire (EORTC QLQ-H&N35)
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KEPK FKUI-RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
Questions about this trial
What is this clinical trial studying?
A study testing Verum Acupuncture in people with Cancer and Nasopharyngeal Carcinoma, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imelda Dimara, MD (+6282319769944, imeldadimara560@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Monitored 2 times per week for 3 weeks, and followed up again at week 4 without intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.