Cancer, BreastNCT02964286
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression
A study testing The Electric vibrating massager,SAMPO® in people with Cancer, Breast and Acupressure, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Cancer, Breast, Acupressure, Hematopoiesis
- What is being tested?
- The Electric vibrating massager,SAMPO®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed of gynecologic cancer, regardless of stage.
- receiving initial chemotherapy.
- ability to write informed consent.
- between 20 to 70 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University
Taipei, 110
Wen-Chi Liu, MSc, 02-227372181 ext. 1300, 116085@tmuh.org.tw
Ya-Wen Shih, MSc
About this study
Official title: The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression Among Patients With Cancer
In this proposed project, the investigator will estimate the effect of massotherapy of acupoints on alleviating chemotherapy-induced myelosuppression among patients with cancer.
Read the 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.
- Conditions
- Cancer, Breast, Acupressure, Hematopoiesis
- Being tested
- The Electric vibrating massager,SAMPO®
- Keywords
- Cancer, Acupressure, Hematopoietic Cell Growth Factors
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cancer, BreastStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiu-Ting Tsai, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964286
- Sponsor's protocol ID
- TMU-JIRB: 201501030
- Status last verified
- Jul 2016
- First submitted
- 31 Oct 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21846575Goh 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.
PubMed 22876727Mason 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.
PubMed 23576689Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Singh 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.
PubMed 23401030Behrens 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.
PubMed 23354983Santoso 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.
PubMed 22366589Lee 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.
PubMed 22818936Wu 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.
PubMed 23274845Lu 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.
PubMed 19552597Ye 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.
PubMed 11977512Ye 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.
PubMed 17393618Han 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.
PubMed 21058473Raghavendran 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.
PubMed 22523542Jong 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.
PubMed 17063830
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression Among Patients With Cancer
- ClinicalTrials.gov ID
- NCT02964286
- Acronym / sponsor ID
- TMU-JIRB: 201501030
- Conditions
- Cancer, Breast, Acupressure, Hematopoiesis
- Keywords
- Cancer, Acupressure, Hematopoietic Cell Growth Factors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Device: The Electric vibrating massager,SAMPO®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. |
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- newly diagnosed of gynecologic cancer, regardless of stage.
- receiving initial chemotherapy.
- ability to write informed consent.
- between 20 to 70 years old.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Acupressure group |
Primary outcome
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosuppression Among Patients With Cancer.
Time frame: Two years
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Results publication: PubMed 21846575Wen 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 publication: PubMed 22876727Goh 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 publication: PubMed 23576689Mason 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 publication: PubMed 4053261Godin 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 publication: PubMed 23401030Singh 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 publication: PubMed 23354983Behrens 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 publication: PubMed 22366589Santoso 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 publication: PubMed 22818936Lee 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 publication: PubMed 23274845Wu 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 publication: PubMed 19552597Lu 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 publication: PubMed 11977512Ye 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 publication: PubMed 17393618Ye 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiu-Ting Tsai, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Electric vibrating massager,SAMPO® in people with Cancer, Breast and Acupressure, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Wen Shih, MSc (0978986983, stacy0419@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosuppression Among Patients With Cancer. (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964286, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.