AcupunctureNCT04249921
Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base
An observational study of Acupuncture and Tumor, Brain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity. The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acupuncture, Tumor, Brain, Skull Base Tumor
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2019to 4 Oct 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients of cerebellopontine angle (CPA) tumors in skull base.
Who may be able to join
- The patients who have been diagnosed Cerebellopontine Angle Tumor by neurosurgeons.
- The Patients who have been undergoned the surgery of tumor
- Not receiving acupuncture for other diseases (needle stimulate for body ) or any rehabilitation treatment at the same time
- Voluntary participation in this study
Who cannot join
- Taking anticoagulant drugs or who have coagulopathy
- Pregnant women, especially pregnant women with habitual abortion
- Skin infections
- Acupuncture phobia (this study has invasive treatment: acupuncture)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Center for Traditional Medicine, Taipei VGH
Taipei, 11217
Fang-Pey Chen, MD, +886-2-2875-7453, fpchen@vghtpe.gov.tw
About this study
Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity. The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors.
Cerebellopontine angle (CPA) tumors are the most common neoplasms in the posterior skull base,accounting for 5-10% of skull base tumors.Some different kinds of tumors can grow in cerebellopontine angle. The tumors are more likely to cause some symptoms when they grow large enough to put pressure on the brain.
Read more
A common traditional treatment for skull base tumors is neurosurgery-craniotomy. However, after the operation, brain may be injured with hematoma, and the instruments used are in contact with the brain. It is still inevitable that there will have complications of minor and major nerve damages, such as facial paralysis,trigeminal neuralgia, tinnitus, sports disorders (ataxia) and so on.
Acupuncture has a unique effect on the treatment of the human nervous system. Aim of the study is used acupuncture to improve the complications of the surgery of Cerebellopontine angle tumors in skull base.
Read the detailed description
Skull base has clinically unique importance:it is the anatomic junction of the neural and facial viscerocranium,supports human brain and supports that contains the neurovascular structures entering or exiting the skull,it divided into anterior,middle and posterior skull base.Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity ,tumors most grow inside the skull base, and a few are formed outside because the tumor may originate from the base of skull or elsewhere in the body (metastatic).The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors.
Cerebellopontine angle (CPA) tumors are common skull base tumors in posterior skull base. CP angle located below the cerebrum, between the pons and the cerebellum and between the superior and inferior limbs of the cerebellopontine fissure, it is a V-shaped angular cleft. About 6%-10% of skull base tumors are in the cerebellopontine angle (CPA). 90% of tumors in this area(CPA) are vestibular schwannoma (acoustic neuromas), 3% are meningioma, and the rest are primary cholesteatoma (lipoma),facial nerve schwannoma ,angioma as well as arachnoid cyst etc..
At present, computed tomography (CT) and nuclear magnetic resonance imaging (MRI) can be used to detect and evaluate skull base lesions. When these tumors grow enough to compress the nerves around the brain, the areas where the tumor are pressed could cause some symptoms such as blurred vision, headache, dizziness and other specific symptoms that affect normal life.
A common traditional treatment for skull base tumors is neurosurgery-craniotomy. However, after the operation, the brain may be injured with hematoma, and the instruments used are in contact with the brain. It is still inevitable that there will have complications of minor and major nerve damages, such as facial paralysis and trigeminal neuralgia, tinnitus, sports disorders (ataxia) and so on. If the damages are in serious situations, patients are also possible to be serious infected or in a vegetative state.
Acupuncture has a unique effect on the treatment of the human nervous system. Acupuncture mainly aims to improve the complications of the surgery of Cerebellopontine angle tumors in skull base by eliminating blood stasis, clearing meridians, and strengthening the body.The researchers' selections of acupoints are distributed in Large Intestine,Stomach Meridian,Small Intestine Meridian,Triple Energizer Meridian and Gallbladder Meridian in body.
In the past, some researchers used questionnaires for the quality of life of skull base tumor surgery, and also some researchers used questionnaires to evaluate the efficacy of acupuncture. The rationale of the study is to combine these three-the surgery of CP Angle tumor in skull base,acupuncture and questionnaires.Namely,the researchers use four questionnaires to evaluate the efficacy of acupuncture after surgery of Cerebellopontine Angle tumor in skull base.
- Conditions
- Acupuncture, Tumor, Brain, Skull Base Tumor, Cerebellopontine Angle Tumor, Complication of Treatment, Quality of Life
- Medical subject headings
- Brain Neoplasms, Skull Base Neoplasms, Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 1. Use acupuncture to treat the patients who received the surgery of CPA tumor. Acupoints of reference: Yifeng(TE17),Tinggong(SI19),Xiaguan(ST07),Wind Pool(GB20),Outer Pass(SJ5),Union Valley(LI4),Yang Mound Spring(GB34),Leg Three Li(ST36). 2. Use questionnaires to evaluate.The questionnaires including House-Brackmann Grading Scale,WHOQOL-BREF Taiwan Version,Functional Assessment of Cancer Therapy: General(FACT-G),Visual Analogue Scale(VAS). | |
| Control | 1.Use questionnaires to evaluate.The questionnaires including House-Brackmann Grading Scale,WHOQOL-BREF Taiwan Version,Functional Assessment of Cancer Therapy: General(FACT-G),Visual Analogue Scale(VAS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
WHOQOL-BREF Taiwan Version
Evaluate the quality of life after acupuncture treatment, use WHOQOL-BREF Taiwan Version questionnaire. Scale: 0~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.
Measured: 8 weeks
Visual Analogue Scale: VAS
measurement for pain,to assess the pain degree. Scale: 0~100 mm, higher scores, higher pain . Counted by each time recording.
Measured: 8 weeks
Functional Assessment of Cancer Therapy: General(FACT-G)
Evaluate the quality of life for " the patients of CPA tumor in skull base " after acupuncture treatment,there are four parts,physiology,social and family, emotion,function.Scale: 0~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.
Measured: 8 weeks
House-Brackmann grading scale
measurement and evaluate the level for the patients of facial paralysis after surgery of CPA tumor in skull base.Measure the upwards and outwards movement situation of eyebrows and mouth. Each reference point scores 1 point for each 0.25 cm movement, up to a maximum of 1 cm. The scores are then added together, to give a number out of 8.After that, the scale of facial paralysis corresponding to the score was divided into five levels, with the first level being the mildest and the fifth level being the most severe.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start20 Nov 2019
- Primary completion4 Oct 2020 (estimated)
- Study completion4 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ta-Peng Wu, MD/Master, Study director, tpwu@vghtpe.gov.tw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249921
- Sponsor's protocol ID
- 2019-09-001AU
- Status last verified
- Jan 2020
- First submitted
- 8 Dec 2019
- Last updated
- 31 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Memari F, Hassannia F, Abtahi SH. Surgical Outcomes of Cerebellopontine angle Tumors in 50 Cases. Iran J Otorhinolaryngol. 2015 Jan;27(78):29-34.
PubMed 25745609Bonneville F, Savatovsky J, Chiras J. Imaging of cerebellopontine angle lesions: an update. Part 1: enhancing extra-axial lesions. Eur Radiol. 2007 Oct;17(10):2472-82. doi: 10.1007/s00330-007-0679-x. Epub 2007 Jun 12.
PubMed 17562049Kunimatsu A, Kunimatsu N. Skull Base Tumors and Tumor-Like Lesions: A Pictorial Review. Pol J Radiol. 2017 Jul 25;82:398-409. doi: 10.12659/PJR.901937. eCollection 2017.
PubMed 28811848Gil Z, Fliss DM. Quality of life in patients with skull base tumors: current status and future challenges. Skull Base. 2010 Jan;20(1):11-8. doi: 10.1055/s-0029-1242979.
PubMed 20592852Roser F, Dimostheni A, Elhammady MS, Recinos P, Rigante L. Response to: Phillips M. et al. "Safety of commercial airflight in patients with brain tumors: a case series". Journal of Neuro-Oncology (2018) 139:617-623. J Neurooncol. 2019 Apr;142(2):393-394. doi: 10.1007/s11060-018-03088-6. Epub 2019 Jan 21. No abstract available.
PubMed 30666464Witgert ME, Veramonti T, Hanna E. Instruments for estimation of health-related quality of life in patients with skull base neoplasms. Skull Base. 2010 Jan;20(1):5-10. doi: 10.1055/s-0029-1242978.
PubMed 20592851Biswas D, Marnane C, Mal R, Baldwin D. Benign extracranial nerve sheath tumors of the skull base: postoperative morbidity and management. Skull Base. 2008 Mar;18(2):99-106. doi: 10.1055/s-2007-991109.
PubMed 18769654Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, Shen X, Lao L. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203. doi: 10.1155/2013/581203. Epub 2013 Mar 20.
PubMed 23573135Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician. 2003 Aug;49:985-9.
PubMed 12943357Chen MH, Chen MH, Huang JS. Cervical subdural empyema following acupuncture. J Clin Neurosci. 2004 Nov;11(8):909-11. doi: 10.1016/j.jocn.2004.02.011.
PubMed 15519876Giovagnoli AR. Quality of life in patients with stable disease after surgery, radiotherapy, and chemotherapy for malignant brain tumour. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):358-63. doi: 10.1136/jnnp.67.3.358.
PubMed 10449559Zhang R, Wu T, Wang R, Wang D, Liu Q. Compare the efficacy of acupuncture with drugs in the treatment of Bell's palsy: A systematic review and meta-analysis of RCTs. Medicine (Baltimore). 2019 May;98(19):e15566. doi: 10.1097/MD.0000000000015566.
PubMed 31083225Qiu WQ, Claunch J, Kong J, Nixon EE, Fang J, Li M, Vangel M, Hui KK. The effects of acupuncture on the brain networks for emotion and cognition: an observation of gender differences. Brain Res. 2010 Nov 29;1362:56-67. doi: 10.1016/j.brainres.2010.09.040. Epub 2010 Sep 17.
PubMed 20851113Kim YD, Park JH, Yang SH, Kim IS, Hong JT, Sung JH, Son BC, Lee SW. Pain assessment in brain tumor patients after elective craniotomy. Brain Tumor Res Treat. 2013 Apr;1(1):24-7. doi: 10.14791/btrt.2013.1.1.24. Epub 2013 Apr 30.
PubMed 24904885Xiao X, Zheng Q, Shi Y, Zhang L, Zhao L, Zhou S, Zhang W, Cao W, Liu Y, Li Y. Association of Patients' Characteristics with Acupuncture Treatment Outcomes in Treating Bell's Palsy: Results from a Randomised Controlled Trial. Evid Based Complement Alternat Med. 2019 Aug 15;2019:6073484. doi: 10.1155/2019/6073484. eCollection 2019.
PubMed 31511780
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base
- ClinicalTrials.gov ID
- NCT04249921
- Acronym / sponsor ID
- 2019-09-001AU
- Conditions
- Acupuncture, Tumor, Brain, Skull Base Tumor, Cerebellopontine Angle Tumor, Complication of Treatment, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 4 Oct 2020 (estimated)
- Study completion
- 4 Oct 2020 (estimated)
- First posted
- 31 Jan 2020 (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.
Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity. The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors.
Cerebellopontine angle (CPA) tumors are the most common neoplasms in the posterior skull base,accounting for 5-10% of skull base tumors.Some different kinds of tumors can grow in cerebellopontine angle. The tumors are more likely to cause some symptoms when they grow large enough to put pressure on the brain.
A common traditional treatment for skull base tumors is neurosurgery-craniotomy. However, after the operation, brain may be injured with hematoma, and the instruments used are in contact with the brain. It is still inevitable that there will have complications of minor and major nerve damages, such as facial paralysis,trigeminal neuralgia, tinnitus, sports disorders (ataxia) and so on.
Acupuncture has a unique effect on the treatment of the human nervous system. Aim of the study is used acupuncture to improve the complications of the surgery of Cerebellopontine angle tumors in skull base.
Detailed description
Skull base has clinically unique importance:it is the anatomic junction of the neural and facial viscerocranium,supports human brain and supports that contains the neurovascular structures entering or exiting the skull,it divided into anterior,middle and posterior skull base.Skull base tumors are a type of tumor that grow in the area of several skulls behind the cranial cavity ,tumors most grow inside the skull base, and a few are formed outside because the tumor may originate from the base of skull or elsewhere in the body (metastatic).The incidence rate is 2 to 18 per 100,000 people per year; males and females are likely to have a proportional difference in the types of skull base tumors.
Cerebellopontine angle (CPA) tumors are common skull base tumors in posterior skull base. CP angle located below the cerebrum, between the pons and the cerebellum and between the superior and inferior limbs of the cerebellopontine fissure, it is a V-shaped angular cleft. About 6%-10% of skull base tumors are in the cerebellopontine angle (CPA). 90% of tumors in this area(CPA) are vestibular schwannoma (acoustic neuromas), 3% are meningioma, and the rest are primary cholesteatoma (lipoma),facial nerve schwannoma ,angioma as well as arachnoid cyst etc..
At present, computed tomography (CT) and nuclear magnetic resonance imaging (MRI) can be used to detect and evaluate skull base lesions. When these tumors grow enough to compress the nerves around the brain, the areas where the tumor are pressed could cause some symptoms such as blurred vision, headache, dizziness and other specific symptoms that affect normal life.
A common traditional treatment for skull base tumors is neurosurgery-craniotomy. However, after the operation, the brain may be injured with hematoma, and the instruments used are in contact with the brain. It is still inevitable that there will have complications of minor and major nerve damages, such as facial paralysis and trigeminal neuralgia, tinnitus, sports disorders (ataxia) and so on. If the damages are in serious situations, patients are also possible to be serious infected or in a vegetative state.
Acupuncture has a unique effect on the treatment of the human nervous system. Acupuncture mainly aims to improve the complications of the surgery of Cerebellopontine angle tumors in skull base by eliminating blood stasis, clearing meridians, and strengthening the body.The researchers' selections of acupoints are distributed in Large Intestine,Stomach Meridian,Small Intestine Meridian,Triple Energizer Meridian and Gallbladder Meridian in body.
In the past, some researchers used questionnaires for the quality of life of skull base tumor surgery, and also some researchers used questionnaires to evaluate the efficacy of acupuncture. The rationale of the study is to combine these three-the surgery of CP Angle tumor in skull base,acupuncture and questionnaires.Namely,the researchers use four questionnaires to evaluate the efficacy of acupuncture after surgery of Cerebellopontine Angle tumor in skull base.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | –1. Use acupuncture to treat the patients who received the surgery of CPA tumor. Acupoints of reference: Yifeng(TE17),Tinggong(SI19),Xiaguan(ST07),Wind Pool(GB20),Outer Pass(SJ5),Union Valley(LI4),Yang Mound Spring(GB34),Leg Three Li(ST36). 2. Use questionnaires to evaluate.The questionnaires including House-Brackmann Grading Scale,WHOQOL-BREF Taiwan Version,Functional Assessment of Cancer Therapy: General(FACT-G),Visual Analogue Scale(VAS). |
| Control | – | –1.Use questionnaires to evaluate.The questionnaires including House-Brackmann Grading Scale,WHOQOL-BREF Taiwan Version,Functional Assessment of Cancer Therapy: General(FACT-G),Visual Analogue Scale(VAS). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients of cerebellopontine angle (CPA) tumors in skull base.
Key inclusion criteria (4 listed)
- The patients who have been diagnosed Cerebellopontine Angle Tumor by neurosurgeons.
- The Patients who have been undergoned the surgery of tumor
- Not receiving acupuncture for other diseases (needle stimulate for body ) or any rehabilitation treatment at the same time
- Voluntary participation in this study
Key exclusion criteria (4 listed)
- Taking anticoagulant drugs or who have coagulopathy
- Pregnant women, especially pregnant women with habitual abortion
- Skin infections
- Acupuncture phobia (this study has invasive treatment: acupuncture)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
WHOQOL-BREF Taiwan Version
Time frame: 8 weeks
Evaluate the quality of life after acupuncture treatment, use WHOQOL-BREF Taiwan Version questionnaire. Scale: 0~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.
Visual Analogue Scale: VAS
Time frame: 8 weeks
measurement for pain,to assess the pain degree. Scale: 0~100 mm, higher scores, higher pain . Counted by each time recording.
Functional Assessment of Cancer Therapy: General(FACT-G)
Time frame: 8 weeks
Evaluate the quality of life for " the patients of CPA tumor in skull base " after acupuncture treatment,there are four parts,physiology,social and family, emotion,function.Scale: 0~100, higher scores, better life quality. Counted by each time recording and using mode conversion to get final scale.
House-Brackmann grading scale
Time frame: 8 weeks
measurement and evaluate the level for the patients of facial paralysis after surgery of CPA tumor in skull base.Measure the upwards and outwards movement situation of eyebrows and mouth. Each reference point scores 1 point for each 0.25 cm movement, up to a maximum of 1 cm. The scores are then added together, to give a number out of 8.After that, the scale of facial paralysis corresponding to the score was divided into five levels, with the first level being the mildest and the fifth level being the most severe.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Results publication: PubMed 25745609Memari F, Hassannia F, Abtahi SH. Surgical Outcomes of Cerebellopontine angle Tumors in 50 Cases. Iran J Otorhinolaryngol. 2015 Jan;27(78):29-34.
- Results publication: PubMed 17562049Bonneville F, Savatovsky J, Chiras J. Imaging of cerebellopontine angle lesions: an update. Part 1: enhancing extra-axial lesions. Eur Radiol. 2007 Oct;17(10):2472-82. doi: 10.1007/s00330-007-0679-x. Epub 2007 Jun 12.
- Results publication: PubMed 28811848Kunimatsu A, Kunimatsu N. Skull Base Tumors and Tumor-Like Lesions: A Pictorial Review. Pol J Radiol. 2017 Jul 25;82:398-409. doi: 10.12659/PJR.901937. eCollection 2017.
- Results publication: PubMed 20592852Gil Z, Fliss DM. Quality of life in patients with skull base tumors: current status and future challenges. Skull Base. 2010 Jan;20(1):11-8. doi: 10.1055/s-0029-1242979.
- Results publication: PubMed 30666464Roser F, Dimostheni A, Elhammady MS, Recinos P, Rigante L. Response to: Phillips M. et al. "Safety of commercial airflight in patients with brain tumors: a case series". Journal of Neuro-Oncology (2018) 139:617-623. J Neurooncol. 2019 Apr;142(2):393-394. doi: 10.1007/s11060-018-03088-6. Epub 2019 Jan 21. No abstract available.
- Results publication: PubMed 20592851Witgert ME, Veramonti T, Hanna E. Instruments for estimation of health-related quality of life in patients with skull base neoplasms. Skull Base. 2010 Jan;20(1):5-10. doi: 10.1055/s-0029-1242978.
- Results publication: PubMed 18769654Biswas D, Marnane C, Mal R, Baldwin D. Benign extracranial nerve sheath tumors of the skull base: postoperative morbidity and management. Skull Base. 2008 Mar;18(2):99-106. doi: 10.1055/s-2007-991109.
- Results publication: PubMed 23573135Xu S, Wang L, Cooper E, Zhang M, Manheimer E, Berman B, Shen X, Lao L. Adverse events of acupuncture: a systematic review of case reports. Evid Based Complement Alternat Med. 2013;2013:581203. doi: 10.1155/2013/581203. Epub 2013 Mar 20.
- Results publication: PubMed 12943357Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician. 2003 Aug;49:985-9.
- Results publication: PubMed 15519876Chen MH, Chen MH, Huang JS. Cervical subdural empyema following acupuncture. J Clin Neurosci. 2004 Nov;11(8):909-11. doi: 10.1016/j.jocn.2004.02.011.
- Results publication: PubMed 10449559Giovagnoli AR. Quality of life in patients with stable disease after surgery, radiotherapy, and chemotherapy for malignant brain tumour. J Neurol Neurosurg Psychiatry. 1999 Sep;67(3):358-63. doi: 10.1136/jnnp.67.3.358.
- Results publication: PubMed 31083225Zhang R, Wu T, Wang R, Wang D, Liu Q. Compare the efficacy of acupuncture with drugs in the treatment of Bell's palsy: A systematic review and meta-analysis of RCTs. Medicine (Baltimore). 2019 May;98(19):e15566. doi: 10.1097/MD.0000000000015566.
- Individual participant dataSharing planned: Undecided
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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.
Ta-Peng Wu, MD/Master study director
tpwu@vghtpe.gov.tw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acupuncture and Tumor, Brain, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 inclusion and 4 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 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Fang-Pey Chen, MD (+886976185588, fpchenchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHOQOL-BREF Taiwan Version (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04249921, which also lists 15 linked publications.
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 31 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.