The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression

Sponsor
Taipei Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02964286
Collaborator
(none)
200
1
2
41
4.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The Electric vibrating massager,SAMPO®
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Acupoint Massotherapy on Relieving Chemotherapy-induced Myelosupression Among Patients With Cancer
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acupressure group

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®
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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taipei Medical University Taipei Taiwan 110

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Principal Investigator: Hsiu-Ting Tsai, PhD, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Medical University
ClinicalTrials.gov Identifier:
NCT02964286
Other Study ID Numbers:
  • TMU-JIRB: 201501030
First Posted:
Nov 16, 2016
Last Update Posted:
Nov 30, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Taipei Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2016