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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02663063
Other study ID # 2015-10-005A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date September 2017

Study information

Verified date February 2023
Source Taipei Veterans General Hospital, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
SSP treatment
SSP treatment 5 times a week

Locations

Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Symptom severity score Questionnaire for evaluating the severity of symptoms One week after treatment
Secondary Quality of life Questionnaire for evaluating quality of life One week after treatment
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