search
Back to results

The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression

Primary Purpose

Cancer, Breast, Acupressure, Hematopoiesis

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
The Electric vibrating massager,SAMPO®
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Breast focused on measuring Cancer, Acupressure, Hematopoietic Cell Growth Factors

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Taipei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupressure group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 31, 2016
Last Updated
November 28, 2016
Sponsor
Taipei Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT02964286
Brief Title
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression
Official Title
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression Among Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Chemotherapy is mainly used to treat and control the progression of gynecological cancer, bone marrow suppression the evil side effects after chemotherapy, which may decreasing immune function and further causes serious fatal infections. Acupuncture is a valid intervention in medical practice and has been used for the improvement of chemotherapy-induced leucopenia. In a systematic meta-analysis study showed that acupoints stimulation has immunomodulatory effect for therapy induced bone marrow suppression in cancer patients. Therefore, in the acupressure group, the technique used is the electric vibrating massager, and patients are taught to apply the strong mode on the 15 specific points,5 min each, 3 times a day during chemotherapy.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); and Baihui (GV20). The patients of the control group are not admitted any acupoints press-related interventions mentioned above. The purpose of this study is to evaluate the effectiveness of non-invasive acupressure on the prevention of chemotherapy-induced myelosuppression among patients with cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Acupressure, Hematopoiesis
Keywords
Cancer, Acupressure, Hematopoietic Cell Growth Factors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients of the control group are not admitted any acupoints press-related interventions, only take clinical treatment protocol as usual.
Intervention Type
Device
Intervention Name(s)
The Electric vibrating massager,SAMPO®
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosuppression Among Patients With Cancer.
Description
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)
Time Frame
Two years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: newly diagnosed of gynecologic cancer, regardless of stage. receiving initial chemotherapy. ability to write informed consent. between 20 to 70 years old. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Wen Shih, MSc
Phone
0978986983
Email
stacy0419@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiu-Ting Tsai, PhD
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen-Chi Liu, MSc
Phone
02-227372181
Ext
1300
Email
116085@tmuh.org.tw
First Name & Middle Initial & Last Name & Degree
Ya-Wen Shih, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21846575
Citation
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.
Results Reference
result
PubMed Identifier
22876727
Citation
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.
Results Reference
result
PubMed Identifier
23576689
Citation
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.
Results Reference
result
PubMed Identifier
4053261
Citation
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.
Results Reference
result
PubMed Identifier
23401030
Citation
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.
Results Reference
result
PubMed Identifier
23354983
Citation
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.
Results Reference
result
PubMed Identifier
22366589
Citation
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.
Results Reference
result
PubMed Identifier
22818936
Citation
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.
Results Reference
result
PubMed Identifier
23274845
Citation
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.
Results Reference
result
PubMed Identifier
19552597
Citation
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.
Results Reference
result
PubMed Identifier
11977512
Citation
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.
Results Reference
result
PubMed Identifier
17393618
Citation
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.
Results Reference
result
PubMed Identifier
21058473
Citation
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.
Results Reference
result
PubMed Identifier
22523542
Citation
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.
Results Reference
result
PubMed Identifier
17063830
Citation
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.
Results Reference
result
PubMed Identifier
11152056
Citation
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.
Results Reference
result
PubMed Identifier
16818620
Citation
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.
Results Reference
result
PubMed Identifier
21439274
Citation
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.
Results Reference
result

Learn more about this trial

The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression

We'll reach out to this number within 24 hrs