The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression

Cancer, Breast Clinical Trial

Official title:

The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression Among Patients With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964286
• Other study ID #: TMU-JIRB: 201501030
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2016
• Last updated: November 28, 2016
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: July 2016
• Source: Taipei Medical University
• Contact: Ya-Wen Shih, MSc
• Phone: 0978986983
• Email: stacy0419[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acupressure
• Breast Neoplasms
• Cancer, Breast
• Hematopoiesis

Intervention

Device:
• The Electric vibrating massager,SAMPO®
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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (18)

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 — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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 — View 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 randomi — View 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):115 — View 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.003373 — View 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. — View Citation

Singh AA, Jones LW, Antonelli JA, Gerber L, Calloway EE, Shuler KH, Freedland SJ, Grant DJ, Hoyo C, Bañez 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.277 — View 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 Ac — View 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/S01 — View 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. — View 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. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No