NCT02964286

Brief Summary

In this proposed project, the investigator will estimate the effect of massotherapy of acupoints on alleviating chemotherapy-induced myelosuppression among patients with cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 30, 2016

Status Verified

July 1, 2016

Enrollment Period

3 years

First QC Date

October 31, 2016

Last Update Submit

November 28, 2016

Conditions

Cancer, BreastAcupressureHematopoiesis

Keywords

CancerAcupressureHematopoietic Cell Growth Factors

Outcome Measures

Primary Outcomes (1)

  • The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosuppression Among Patients With Cancer.

    To evaluate the effectiveness and mechanisms of acupressure in the prevention and diminishing of chemotherapy-induced myelosuppression among patients with gynecologic cancer. Using a composite outcome measure consisting of blood counts and plasma. Blood counts: white blood cells, platelets, hemoglobin and red blood cells. Plasma: Stem cell factor(SCF)、Granulocyte-macrophage colony-stimulating factor(GM-CSF)、Interleukin-1(IL-1)、 Interleukin-2(IL-2)、Interleukin-3 (IL-3)、Interleukin-6(IL-6)、Interleukin-8(IL-8)、Interleukin-12(IL-12)、Transforming growth factor-B (TGF-B)、Interferon gamma(IFN-r)、Tumor necrosis factor-a(TNF-a)

    Two years

Study Arms (2)

Acupressure group

EXPERIMENTAL

The intervention technique used is ''The electric vibrating massager'', ''SAMPO®'', and patients are taught to apply the strong mode on the 15 specific points,5 min each, 3 times a day from Monday to Friday during chemotherapy course. The intervention follows the points are used to stimulate the hematopoietic function. including Hegu (LI4), Quchi (LI11), Xuehai (SP10); Sanyin-jiao (SP6), Taixi (K3), Zusanli (ST36), Taichong (LV3), Baihui (GV20). Before the study, the trained study nurses teach patients that how to use the technique and stuck adhesive dots label on each specific acupoints.

Device: The Electric vibrating massager,SAMPO®

Control group

NO INTERVENTION

The patients of the control group are not admitted any acupoints press-related interventions, only take clinical treatment protocol as usual.

Interventions

The Electric vibrating massager,SAMPO®DEVICE

The technique used is The electric vibrating massager ''SAMPO®'', and patients are taught to apply the strong mode on the 15 specific points,5 min each, 3 times a day from Monday to Friday during chemotherapy course. The intervention follow the points are used to stimulate the hematopoietic function. According to their anatomical location: upper extremity are Hegu (LI4), Quchi (LI11); lower extremity are Xuehai (SP10); Sanyin-jiao (SP6), Taixi (K3), Zusanli (ST36), Taichong (LV3); and the top of head is Baihui (GV20). The used of all the points, except for Baihui (GV20), is bilateral.

Acupressure group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed of gynecologic cancer, regardless of stage.
  • receiving initial chemotherapy.
  • ability to write informed consent.
  • between 20 to 70 years old.

You may not qualify if:

  • history of severe cardiac disorder.
  • suffering from the hematological diseases such as hemolytic anemia.
  • cancer patients with lymphoedema at the area of the acupressure points.
  • diagnosed combine with other cancers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

RECRUITING

Related Publications (18)

  • Wen CP, Wai JP, Tsai MK, Yang YC, Cheng TY, Lee MC, Chan HT, Tsao CK, Tsai SP, Wu X. Minimum amount of physical activity for reduced mortality and extended life expectancy: a prospective cohort study. Lancet. 2011 Oct 1;378(9798):1244-53. doi: 10.1016/S0140-6736(11)60749-6. Epub 2011 Aug 16.

    PMID: 21846575RESULT

  • Goh J, Kirk EA, Lee SX, Ladiges WC. Exercise, physical activity and breast cancer: the role of tumor-associated macrophages. Exerc Immunol Rev. 2012;18:158-76.

    PMID: 22876727RESULT

  • Mason C, Alfano CM, Smith AW, Wang CY, Neuhouser ML, Duggan C, Bernstein L, Baumgartner KB, Baumgartner RN, Ballard-Barbash R, McTiernan A. Long-term physical activity trends in breast cancer survivors. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1153-61. doi: 10.1158/1055-9965.EPI-13-0141. Epub 2013 Apr 10.

    PMID: 23576689RESULT

  • Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.

    PMID: 4053261RESULT

  • Singh AA, Jones LW, Antonelli JA, Gerber L, Calloway EE, Shuler KH, Freedland SJ, Grant DJ, Hoyo C, Banez LL. Association between exercise and primary incidence of prostate cancer: does race matter? Cancer. 2013 Apr 1;119(7):1338-43. doi: 10.1002/cncr.27791. Epub 2013 Feb 11.

    PMID: 23401030RESULT

  • Behrens G, Matthews CE, Moore SC, Freedman ND, McGlynn KA, Everhart JE, Hollenbeck AR, Leitzmann MF. The association between frequency of vigorous physical activity and hepatobiliary cancers in the NIH-AARP Diet and Health Study. Eur J Epidemiol. 2013 Jan;28(1):55-66. doi: 10.1007/s10654-013-9767-1. Epub 2013 Jan 26.

    PMID: 23354983RESULT

  • Santoso JT, Crigger M, English E, Wan J, Likes W. Smoking cessation counseling in women with genital intraepithelial neoplasia. Gynecol Oncol. 2012 Jun;125(3):716-9. doi: 10.1016/j.ygyno.2012.02.018. Epub 2012 Feb 21.

    PMID: 22366589RESULT

  • Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.

    PMID: 22818936RESULT

  • Wu Y, Zhang D, Kang S. Physical activity and risk of breast cancer: a meta-analysis of prospective studies. Breast Cancer Res Treat. 2013 Feb;137(3):869-82. doi: 10.1007/s10549-012-2396-7. Epub 2012 Dec 30.

    PMID: 23274845RESULT

  • Lu W, Matulonis UA, Doherty-Gilman A, Lee H, Dean-Clower E, Rosulek A, Gibson C, Goodman A, Davis RB, Buring JE, Wayne PM, Rosenthal DS, Penson RT. Acupuncture for chemotherapy-induced neutropenia in patients with gynecologic malignancies: a pilot randomized, sham-controlled clinical trial. J Altern Complement Med. 2009 Jul;15(7):745-53. doi: 10.1089/acm.2008.0589.

    PMID: 19552597RESULT

  • Ye F, Chen S, Liu W. Effects of electro-acupuncture on immune function after chemotherapy in 28 cases. J Tradit Chin Med. 2002 Mar;22(1):21-3.

    PMID: 11977512RESULT

  • Ye F, Liu D, Wang S, Xu L. Effects of electro-acupuncture on T cell subpopulations, NK activity, humoral immunity and leukocyte count in patients undergoing chemotherapy. J Tradit Chin Med. 2007 Mar;27(1):19-21.

    PMID: 17393618RESULT

  • Han YF, Gong Z, Huang LQ, Xia X, Zhao WJ. [Clinical study on acupuncture for leukopenia induced by chemotherapy]. Zhongguo Zhen Jiu. 2010 Oct;30(10):802-5. Chinese.

    PMID: 21058473RESULT

  • Raghavendran HR, Sathyanath R, Shin J, Kim HK, Han JM, Cho J, Son CG. Panax ginseng modulates cytokines in bone marrow toxicity and myelopoiesis: ginsenoside Rg1 partially supports myelopoiesis. PLoS One. 2012;7(4):e33733. doi: 10.1371/journal.pone.0033733. Epub 2012 Apr 16.

    PMID: 22523542RESULT

  • Jong MS, Hwang SJ, Chen FP. Effects of electro-acupuncture on serum cytokine level and peripheral blood lymphocyte subpopulation at immune-related and non-immune-related points. Acupunct Electrother Res. 2006;31(1-2):45-59. doi: 10.3727/036012906815844337.

    PMID: 17063830RESULT

  • Joos S, Schott C, Zou H, Daniel V, Martin E. Immunomodulatory effects of acupuncture in the treatment of allergic asthma: a randomized controlled study. J Altern Complement Med. 2000 Dec;6(6):519-25. doi: 10.1089/acm.2000.6.519.

    PMID: 11152056RESULT

  • Gautam A, Bepler G. Suppression of lung tumor formation by the regulatory subunit of ribonucleotide reductase. Cancer Res. 2006 Jul 1;66(13):6497-502. doi: 10.1158/0008-5472.CAN-05-4462.

    PMID: 16818620RESULT

  • Tsai HT, Su PH, Lee TH, Tee YT, Lin LY, Yang SF, Wang PH. Significant elevation and correlation of plasma neutrophil gelatinase associated lipocalin and its complex with matrix metalloproteinase-9 in patients with pelvic inflammatory disease. Clin Chim Acta. 2011 Jun 11;412(13-14):1252-6. doi: 10.1016/j.cca.2011.03.021. Epub 2011 Mar 23.

    PMID: 21439274RESULT

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hsiu-Ting Tsai, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Wen Shih, MSc

CONTACT

0978986983stacy0419@hotmail.com

Study Design

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

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 16, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

November 30, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)