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Trial record 66 of 3030 for:    China Medicine University Hospital

Evaluation of the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03626220
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Chien-Chen Huang, China Medical University Hospital

Brief Summary:

Peripheral neuropathy is currently the second most common side effect after chemotherapy, second only to the side effects of blood toxicity. A variety of chemotherapy drugs may induce peripheral neurotoxicity, and cause by the cumulative dose of chemotherapy drugs. Symptoms include sensory parasthesia, feeling dull or numbness, glove-like feeling distributed in the palm. The currently most effective way is to interrupt the treatment or adjust the dose of chemotherapeutic drugs, but it is easy to make patients discontinue chemotherapy. The purpose of this study is to explore the impact of acupuncture on neurological symptoms and quality of life. Three kinds of questionnairs will be used:(1) Brief pain inventory- short form to assess the extent of pain, and the impact of daily life. (2) FACT/GOG-NTX-13 (Version 4) to assess changes in neurological symptoms; (3) WHOQOL-BREF to assess changes in the quality of life of patients. The course of treatment was evaluated for nine weeks. Changes in neurological function and quality of life will be evaluated before treatment, the third week of treatment, the sixth week of treatment, till the ninth week. The aim of this study is to confirm that acupuncture can improve peripheral neuropathy after chemotherapy, in order to enhance breast cancer patients' quality of life, and provide the new opportunity for integrative therapy between Chinese and Western medicine.

Keywords:acupuncture , chemotherapy-induced peripheral neuropathy


Condition or disease Intervention/treatment
Randomized Controlled Trial Breast Cancer Chemotherapy-induced Peripheral Neuropathy Procedure: acupuncture

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation the Efficacy of Acupuncture in Chemotherapy Induced Peripheral Neuropathy
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : October 10, 2019
Estimated Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
acupuncture group
acupuncture with de-chi sensation
Procedure: acupuncture
manually manipulate acupuncture at CV6 and three acupoints on each arms and legs

sham acupuncture group
skin-deep acupuncture without de-chi sensation
Procedure: acupuncture
manually manipulate acupuncture at CV6 and three acupoints on each arms and legs




Primary Outcome Measures :
  1. FACT/GOG-NTX-13 (Version 4) [ Time Frame: 4 times in 9 weeks ]
    Prorated subscale score = [Sum of item scores] x [N of items in subscale]÷ [N of items answered] For all FACIT scales and symptom indices, the higher the score the better the QOL.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
breast cancer patients who complete whole courses of chemotherapy obtain peripheral neuropathy
Criteria

Inclusion Criteria:

  • more than 20 yeas old Female
  • TypeI-III breast cancer patients
  • complete chemotherapy
  • chemotherapeutic agents include taxanes、platinum compounds ect
  • ECOG<3
  • NCI common terminology criteria for adverse events,v4.0: more than grade1 。

Exclusion Criteria:

  • average life expectancy<3months
  • diabetic neuropathy
  • inflammatory neuropathy
  • metabolic neuropathy
  • severe blood coagulopathy or bleeding tendency
  • unstable heart disease
  • neuro-muscular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626220


Contacts
Contact: Chien-Chen Huang(Attending physician), master (06)355-3111 ext 2231 chenchinh2013@gmail.com

Locations
Taiwan
An Nan Hospital,China Medical University Recruiting
Tainan, Taiwan, 709
Contact: Tsai-Wang Chang(Professor), Doctor    +886-6-3553111    D71568@mail.tmanh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Chien-Chen Huang(Attending physician), master Traditional Chinese medcine department, An-Nan Municiple Hospital, China Medical University

Additional Information:
pubmed  This link exits the ClinicalTrials.gov site

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications of Results:
Responsible Party: Chien-Chen Huang, Principal Investigator, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03626220     History of Changes
Other Study ID Numbers: CMUH106-REC2-117
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chien-Chen Huang, China Medical University Hospital:
acupuncture
chemotherapy-induced peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases