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Trial record 37 of 1174 for:    acupuncture

1068GCC Evaluate Efficacy & Explore Mechanism of Acupuncture in Treating Bortezomib-induced Peripheral Neuropathy (BIPN) in Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01541644
Recruitment Status : Completed
First Posted : March 1, 2012
Results First Posted : March 11, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ting Bao, University of Maryland

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Peripheral Neuropathies
Multiple Myeloma
Intervention Device: Acupuncture
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acupuncture
Hide Arm/Group Description

All participants will receive acupuncture treatments over a total of 10 weeks.

Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Period Title: Overall Study
Started 27
Completed 24
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Acupuncture
Hide Arm/Group Description

All participants will receive acupuncture treatments over a total of 10 weeks.

Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants
63
(49 to 77)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
13
  48.1%
Male
14
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)
Hide Description The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.
Time Frame Baseline and 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acupuncture
Hide Arm/Group Description:

All participants will receive acupuncture treatments over a total of 10 weeks.

Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: units on a scale (1 - 100)
13.3  (6.5)
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acupuncture
Hide Arm/Group Description

All participants will receive acupuncture treatments over a total of 10 weeks.

Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.

All-Cause Mortality
Acupuncture
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acupuncture
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acupuncture
Affected / at Risk (%)
Total   0/27 (0.00%) 
TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emily Parks
Organization: University of Maryland Baltimore Greenebaum Cancer Center
Phone: 410-328-7340
Responsible Party: Ting Bao, University of Maryland
ClinicalTrials.gov Identifier: NCT01541644     History of Changes
Other Study ID Numbers: HP-00047788
GCC 1068 ( Other Identifier: University of Maryland Greenebaum Cancer Center )
First Submitted: February 20, 2012
First Posted: March 1, 2012
Results First Submitted: April 21, 2015
Results First Posted: March 11, 2016
Last Update Posted: December 29, 2016