NCT02663063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

January 21, 2016

Last Update Submit

February 20, 2023

Conditions

Cancer

Keywords

Complementary and alternative medicineHospice Palliative Care

Outcome Measures

Primary Outcomes (1)

  • Symptom severity score

    Questionnaire for evaluating the severity of symptoms

    One week after treatment

Secondary Outcomes (1)

  • Quality of life

    One week after treatment

Study Arms (2)

SSP treatment group

EXPERIMENTAL

Case on SSP treatment

Device: SSP treatment

Non-SSP treatment group

SHAM COMPARATOR

Sham SSP treatment

Device: SSP treatment

Interventions

SSP treatmentDEVICE

SSP treatment 5 times a week

Non-SSP treatment groupSSP treatment group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • With implanted devices
  • Not having clear consciousness
  • Expected life span less than 1 week
  • Foreigner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Related 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.

    PMID: 18425927BACKGROUND

  • 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.

    PMID: 17319950BACKGROUND

  • 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.

    PMID: 10923772BACKGROUND

  • 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.

    PMID: 18606019BACKGROUND

  • 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.

    PMID: 21948812BACKGROUND

  • 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.

    PMID: 21448267BACKGROUND

  • 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.

    PMID: 20619198BACKGROUND

  • 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.

    PMID: 19378325BACKGROUND

  • 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.

    PMID: 23341529BACKGROUND

  • 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.

    PMID: 21151679BACKGROUND

  • 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.

    PMID: 15899016BACKGROUND

  • 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.

    PMID: 22641326BACKGROUND

  • 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.

    PMID: 12785044BACKGROUND

  • 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.

    PMID: 22285177BACKGROUND

  • 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.

    PMID: 21062848BACKGROUND

  • 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.

    PMID: 18539767BACKGROUND

  • 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.

    PMID: 7572330BACKGROUND

  • 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.

    PMID: 16552832BACKGROUND

  • 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.

    PMID: 22965186BACKGROUND

  • 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.

    PMID: 20920180BACKGROUND

  • 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.

    PMID: 11545543BACKGROUND

  • 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.

    PMID: 16968323BACKGROUND

  • 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.

    PMID: 22791311BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Shinn-Jang Hwang, MD

    Taipei Veterans General Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2016

First Posted

January 26, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

TW(1)