- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663063
CAM in Hospice Palliative Care in Taiwan
February 20, 2023 updated by: Taipei Veterans General Hospital, Taiwan
The Application of Evidence-Based Chinese Complementary and Alternative Medicine (CAM) in Hospice Palliative Care in Taiwan-The Second and Third Year Project.
The study aims to explore the effects of silver spike point (SSP) treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients.
Study Overview
Detailed Description
The study aims to explore the effects of silver spike point treatment on common symptoms including pain, breathlessness, nausea/vomiting, dry mouth etc. of terminal cancer patients.
We will conducted a pilot study to evaluate the effects on different symptoms and then a prospective study will be conducted after validation of major effects.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cancer patients
- Competent with clear consciousness
- With symptoms of pain, breathlessness, nause/vomiting, dry mouth, generalized discomfort
- Expected life span of at least 1 week
Exclusion Criteria:
- With implanted devices
- Not having clear consciousness
- Expected life span less than 1 week
- Foreigner
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SSP treatment group
Case on SSP treatment
|
SSP treatment 5 times a week
|
|
Sham Comparator: Non-SSP treatment group
Sham SSP treatment
|
SSP treatment 5 times a week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom severity score
Time Frame: One week after treatment
|
Questionnaire for evaluating the severity of symptoms
|
One week after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life
Time Frame: One week after treatment
|
Questionnaire for evaluating quality of life
|
One week after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shinn-Jang Hwang, MD, Taipei Veterans General Hospital, Taipei, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garcia MK, McQuade J, Haddad R, Patel S, Lee R, Yang P, Palmer JL, Cohen L. Systematic review of acupuncture in cancer care: a synthesis of the evidence. J Clin Oncol. 2013 Mar 1;31(7):952-60. doi: 10.1200/JCO.2012.43.5818. Epub 2013 Jan 22.
- Bausewein C, Booth S, Gysels M, Higginson I. Non-pharmacological interventions for breathlessness in advanced stages of malignant and non-malignant diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD005623. doi: 10.1002/14651858.CD005623.pub2.
- Chen FP, Chen TJ, Kung YY, Chen YC, Chou LF, Chen FJ, Hwang SJ. Use frequency of traditional Chinese medicine in Taiwan. BMC Health Serv Res. 2007 Feb 23;7:26. doi: 10.1186/1472-6963-7-26.
- Chiu TY, Hu WY, Chen CY. Prevalence and severity of symptoms in terminal cancer patients: a study in Taiwan. Support Care Cancer. 2000 Jul;8(4):311-3. doi: 10.1007/s005209900112.
- Deng G, Hou BL, Holodny AI, Cassileth BR. Functional magnetic resonance imaging (fMRI) changes and saliva production associated with acupuncture at LI-2 acupuncture point: a randomized controlled study. BMC Complement Altern Med. 2008 Jul 7;8:37. doi: 10.1186/1472-6882-8-37.
- Enblom A, Johnsson A, Hammar M, Onelov E, Steineck G, Borjeson S. Acupuncture compared with placebo acupuncture in radiotherapy-induced nausea--a randomized controlled study. Ann Oncol. 2012 May;23(5):1353-1361. doi: 10.1093/annonc/mdr402. Epub 2011 Sep 23.
- Enblom A, Lekander M, Hammar M, Johnsson A, Onelov E, Ingvar M, Steineck G, Borjeson S. Getting the grip on nonspecific treatment effects: emesis in patients randomized to acupuncture or sham compared to patients receiving standard care. PLoS One. 2011 Mar 23;6(3):e14766. doi: 10.1371/journal.pone.0014766.
- Ernst E, Lee MS. Acupuncture for palliative and supportive cancer care: a systematic review of systematic reviews. J Pain Symptom Manage. 2010 Jul;40(1):e3-5. doi: 10.1016/j.jpainsymman.2010.03.010. No abstract available.
- Garcia MK, Chiang JS, Cohen L, Liu M, Palmer JL, Rosenthal DI, Wei Q, Tung S, Wang C, Rahlfs T, Chambers MS. Acupuncture for radiation-induced xerostomia in patients with cancer: a pilot study. Head Neck. 2009 Oct;31(10):1360-8. doi: 10.1002/hed.21110.
- Hervik J, Mjaland O. Quality of life of breast cancer patients medicated with anti-estrogens, 2 years after acupuncture treatment: a qualitative study. Int J Womens Health. 2010 Sep 28;2:319-25. doi: 10.2147/IJWH.S12809.
- Jedel E. Acupuncture in xerostomia--a systematic review. J Oral Rehabil. 2005 Jun;32(6):392-6. doi: 10.1111/j.1365-2842.2005.01445.x.
- Lang DS. Nonpharmacologic interventions for breathlessness in advanced stages of malignant and nonmalignant diseases. Clin J Oncol Nurs. 2012 Jun 1;16(3):320. doi: 10.1188/12.CJON.320. No abstract available.
- Lewis CR, de Vedia A, Reuer B, Schwan R, Tourin C. Integrating complementary and alternative medicine (CAM) into standard hospice and palliative care. Am J Hosp Palliat Care. 2003 May-Jun;20(3):221-8. doi: 10.1177/104990910302000312.
- Meng Z, Kay Garcia M, Hu C, Chiang J, Chambers M, Rosenthal DI, Peng H, Wu C, Zhao Q, Zhao G, Liu L, Spelman A, Lynn Palmer J, Wei Q, Cohen L. Sham-controlled, randomised, feasibility trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma. Eur J Cancer. 2012 Jul;48(11):1692-9. doi: 10.1016/j.ejca.2011.12.030. Epub 2012 Jan 28.
- O'Sullivan EM, Higginson IJ. Clinical effectiveness and safety of acupuncture in the treatment of irradiation-induced xerostomia in patients with head and neck cancer: a systematic review. Acupunct Med. 2010 Dec;28(4):191-9. doi: 10.1136/aim.2010.002733. Epub 2010 Nov 9.
- Standish LJ, Kozak L, Congdon S. Acupuncture is underutilized in hospice and palliative medicine. Am J Hosp Palliat Care. 2008 Aug-Sep;25(4):298-308. doi: 10.1177/1049909108315916. Epub 2008 Jun 6.
- Sugimoto K, Konda T, Shimahara M, Hyodo M, Kitade T. A clinical study on SSP (silver spike point) electro-therapy combined with splint therapy for temporo-mandibular joint dysfunction. Acupunct Electrother Res. 1995 Jan-Mar;20(1):7-13. doi: 10.3727/036012995816357177.
- Tseng KL, Liu HJ, Tso KY, Woung LC, Su YC, Lin JG. A clinical study of acupuncture and SSP (silver spike point) electro-therapy for dry eye syndrome. Am J Chin Med. 2006;34(2):197-206. doi: 10.1142/S0192415X0600376X.
- Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.
- Vickers AJ, Cronin AM, Maschino AC, Lewith G, Macpherson H, Victor N, Sherman KJ, Witt C, Linde K; Acupuncture Trialists' Collaboration. Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration. Trials. 2010 Sep 28;11:90. doi: 10.1186/1745-6215-11-90.
- Wong R, Sagar CM, Sagar SM. Integration of Chinese medicine into supportive cancer care: a modern role for an ancient tradition. Cancer Treat Rev. 2001 Aug;27(4):235-46. doi: 10.1053/ctrv.2001.0227.
- Xu W, Towers AD, Li P, Collet JP. Traditional Chinese medicine in cancer care: perspectives and experiences of patients and professionals in China. Eur J Cancer Care (Engl). 2006 Sep;15(4):397-403. doi: 10.1111/j.1365-2354.2006.00685.x.
- Zhuang L, Yang Z, Zeng X, Zhua X, Chen Z, Liu L, Meng Z. The preventive and therapeutic effect of acupuncture for radiation-induced xerostomia in patients with head and neck cancer: a systematic review. Integr Cancer Ther. 2013 May;12(3):197-205. doi: 10.1177/1534735412451321. Epub 2012 Jul 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
January 21, 2016
First Submitted That Met QC Criteria
January 25, 2016
First Posted (Estimate)
January 26, 2016
Study Record Updates
Last Update Posted (Estimate)
February 22, 2023
Last Update Submitted That Met QC Criteria
February 20, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2015-10-005A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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