Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base

Quality of Life Clinical Trial

Official title:

Evaluation of Acupuncture Effects for Complications After Surgery of Cerebellopontine Angle Tumor in Skull Base

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04249921
• Other study ID #: 2019-09-001AU
• Status: Recruiting
• Start date: November 20, 2019
• Est. completion date: October 4, 2020

Study information

• Verified date: January 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Fang-Pey Chen, MD
• Phone: +886976185588
• Email: fpchenchen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: October 4, 2020
• Est. primary completion date: October 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. The patients who have been diagnosed Cerebellopontine Angle Tumor by neurosurgeons.

2. The Patients who have been undergoned the surgery of tumor

3. Not receiving acupuncture for other diseases (needle stimulate for body ) or any rehabilitation treatment at the same time

4. Voluntary participation in this study

Exclusion Criteria:

1. Taking anticoagulant drugs or who have coagulopathy

2. Pregnant women, especially pregnant women with habitual abortion

3. Skin infections

4. Acupuncture phobia (this study has invasive treatment: acupuncture)

Related Conditions & MeSH terms

• Acupuncture
• Brain Neoplasms
• Cerebellopontine Angle Tumor
• Complication of Treatment
• Neoplasms
• Neuroma, Acoustic
• Neuromuscular Blockade
• Quality of Life
• Skull Base Neoplasms
• Skull Base Tumor
• Tumor, Brain

Locations

Country	Name	City	State
Taiwan	Center for Traditional Medicine, Taipei VGH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

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Bonneville 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. Epub 2007 Jun 12. Review. — View Citation

Chen MH, Chen MH, Huang JS. Cervical subdural empyema following acupuncture. J Clin Neurosci. 2004 Nov;11(8):909-11. — View Citation

Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician. 2003 Aug;49:985-9. Review. — View Citation

Gil 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. — View Citation

Giovagnoli 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. — View Citation

Kim 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. — View Citation

Kunimatsu 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. Review. — View Citation

Memari F, Hassannia F, Abtahi SH. Surgical Outcomes of Cerebellopontine angle Tumors in 50 Cases. Iran J Otorhinolaryngol. 2015 Jan;27(78):29-34. — View Citation

Qiu 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. — View Citation

Roser 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. — View Citation

Witgert 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. — View Citation

Xiao 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 — View Citation

Xu 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. — View Citation

Zhang 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks
Primary	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.	8 weeks