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Acupuncture for Chemo-Induced Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891618
First Posted: May 1, 2009
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: May 30, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Lymphoma
Myeloma
Peripheral Neuropathy
Intervention: Other: Acupuncture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: April 30, 2009 to March 28, 2013. All recruitment done at the University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 27 participants registered, six participants were registered but excluded before treatment from the study.

Reporting Groups
  Description
Acupuncture Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.

Participant Flow:   Overall Study
    Acupuncture
STARTED   21 
COMPLETED   20 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acupuncture Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.

Baseline Measures
   Acupuncture 
Overall Participants Analyzed 
[Units: Participants]
 21 
Age 
[Units: Years]
Median (Full Range)
 64 
 (46 to 79) 
Gender 
[Units: Participants]
 
Female   5 
Male   16 
Region of Enrollment 
[Units: Participants]
 
United States   21 


  Outcome Measures

1.  Primary:   Mean Neuropathy Severity Score (FACT-GOG-Ntx Total Score Assessment)   [ Time Frame: Baseline to Week 13. Assessments at baseline, once per week during the two treatment phases of the study, and one month (week 13) after the last acupuncture treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Wang, MD / Professor, Lymphoma/Myeloma
Organization: University of Texas MD Anderson Cancer
phone: 713-792-2860
e-mail: CR_Study_Registration@mdanderson.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00891618     History of Changes
Other Study ID Numbers: 2006-0679
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: May 30, 2014
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016