The Application of Evidence-Based Chinese Complementary and Alternative Medicine (CAM) in Hospice Palliative Care in Taiwan
Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Unknown status
CT.gov ID
NCT02663063
Collaborator
(none)
494
1
2
10
49.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Anticipated Enrollment
:
494 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
The Application of Evidence-Based Chinese Complementary and Alternative Medicine (CAM) in Hospice Palliative Care in Taiwan-The Second and Third Year Project.
Study Start Date
:
Dec 1, 2015
Anticipated Primary Completion Date
:
Oct 1, 2016
Anticipated Study Completion Date
:
Oct 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SSP treatment group Case on SSP treatment |
Device: SSP treatment
SSP treatment 5 times a week
|
| Sham Comparator: Non-SSP treatment group Sham SSP treatment |
Device: SSP treatment
SSP treatment 5 times a week
|
Outcome Measures
Primary Outcome Measures
- Symptom severity score [One week after treatment]
Questionnaire for evaluating the severity of symptoms
Secondary Outcome Measures
- Quality of life [One week after treatment]
Questionnaire for evaluating quality of life
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Veterans General Hospital | Taipei | Taiwan | 11217 |
Sponsors and Collaborators
- Taipei Veterans General Hospital, Taiwan
Investigators
- Principal Investigator: Shinn-Jang Hwang, MD, Taipei Veterans General Hospital, Taipei, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Update in: Cochrane Database Syst Rev. 2013;11:CD005623.
- 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.
- 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.
- 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, Onelöv E, Steineck G, Börjeson 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, Onelöv E, Ingvar M, Steineck G, Börjeson 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.
- 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.
- 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. Review.
- Hervik J, Mjåland 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. Review.
- 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. Review.
- 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. Review.
- 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. Review.
- 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. Review.
- 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.
- 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.
- 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. Review.
- 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. Review.
- 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.
- 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. Review.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT02663063
Other Study ID Numbers:
- 2015-10-005A
First Posted:
Jan 26, 2016
Last Update Posted:
Feb 2, 2016
Last Verified:
Jan 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Taipei Veterans General Hospital, Taiwan