Ignite Creation Date:
2024-05-05 @ 9:29 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00891618
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2009-04-30
Brief Title:
Acupuncture for Chemo-Induced Peripheral Neuropathy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Acupuncture for Chemo-induced Peripheral Neuropathy in Multiple Myeloma and Lymphoma Patients
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if giving acupuncture to patients with lymphoma or a plasma cell dyscrasia can help to relieve numbness andor tingling of the feet andor hands that is related to chemotherapy
Detailed Description:
Acupuncture
Acupuncture involves the insertion of small solid sterile needles into specific points on the skin In this study the needles are placed in areas that are intended to help relieve numbness and tingling of the feet and hands Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture
Acupuncture Sessions
Your first acupuncture session will be on the same day as the tests described above if possible If not it will be scheduled for another day that will be no more than about 10 days after the screening visit
You will have an acupuncture session 3 times per week for 4 weeks Weeks 1-4 You will then have 1 week off Week 5 After that you will have an acupuncture session twice per week for 4 more weeks Weeks 6-10 This is a total of 20 sessions In addition to the 20 planned sessions you may also choose to receive an optional 21st acupuncture session at the end-of-study visit that is scheduled for Week 13
For each session you will be placed in a comfortable position and the study doctoracupuncturist will find points on your body where the needles will be placed All study participants will have the needles placed at the same points on the body the hands feet legs abdomen and scalp
Very thin solid sterile stainless steel needles will be used All of the needles are specially made for acupuncture The depth of the needle in the skin and the number of needles used is based on standard acupuncture procedures The needles will remain in place for about 20-30 minutes
Electrical stimulation will be added to some of the needles on the feet and hands This involves placing wires on the needles which are connected to a machine that delivers a weak electrical current through the wires The strength of the electrical current will be changed slowly until it is at a comfortable level for you
Study Procedures
At each session before you receive the acupuncture the following procedures will be performed
Your vital signs will be measured
You will be asked about any drugs you may be taking and any side effects you may be experiencing
The color and coating of your tongue and the quality of your pulse will be recorded
Once a week you will also be asked to complete the same 3 questionnaires as you did at the beginning of the study
Most study visits will last about 1 hour On the weeks that you complete the questionnaires it may add about 15-20 minutes
During the study you may still receive your regular pain treatments If you are receiving Neurontin gabapentin Cymbalta duloxetine andor Lyrica pregabalin you must stay on the same drugs until you go off this study Minor changes in the doses of your pain treatments are allowed but if there is a large change you will be taken off study early
Length of Study Participation
You may receive up to 21 acupuncture sessions over 13 weeks If intolerable side effects or symptoms occur you will be taken off study early
End-of-Study Visit
At Week 13 or if you go off study early for any reason you will have an end-of-study visit If the doctor thinks it is necessary the following procedures will be performed
Your medical history will be recorded
Your vital signs will be measured
You will be asked about any drugs you may be taking and any side effects you may have experienced
You will complete the same 3 questionnaires as before
The 4 nerve tests will be repeated in order to learn if there have been any changes in your nerve function
Your tongue and pulse will be evaluated
After the end-of-study visit your participation in this study will be over
This is an investigational study The acupuncture needles used in this study are commercially available and FDA approved It is considered experimental however to use acupuncture to treat numbness andor tingling in the feet andor hands that is related to chemotherapy
Up to 30 patients will take part in this study All will be enrolled at The University of Texas UT MD Anderson Cancer Center
Acupuncture involves the insertion of small solid sterile needles into specific points on the skin In this study the needles are placed in areas that are intended to help relieve numbness and tingling of the feet and hands Weak electrical stimulation is also applied to the needles to try to improve the treatment effects of the acupuncture
Acupuncture Sessions
Your first acupuncture session will be on the same day as the tests described above if possible If not it will be scheduled for another day that will be no more than about 10 days after the screening visit
You will have an acupuncture session 3 times per week for 4 weeks Weeks 1-4 You will then have 1 week off Week 5 After that you will have an acupuncture session twice per week for 4 more weeks Weeks 6-10 This is a total of 20 sessions In addition to the 20 planned sessions you may also choose to receive an optional 21st acupuncture session at the end-of-study visit that is scheduled for Week 13
For each session you will be placed in a comfortable position and the study doctoracupuncturist will find points on your body where the needles will be placed All study participants will have the needles placed at the same points on the body the hands feet legs abdomen and scalp
Very thin solid sterile stainless steel needles will be used All of the needles are specially made for acupuncture The depth of the needle in the skin and the number of needles used is based on standard acupuncture procedures The needles will remain in place for about 20-30 minutes
Electrical stimulation will be added to some of the needles on the feet and hands This involves placing wires on the needles which are connected to a machine that delivers a weak electrical current through the wires The strength of the electrical current will be changed slowly until it is at a comfortable level for you
Study Procedures
At each session before you receive the acupuncture the following procedures will be performed
Your vital signs will be measured
You will be asked about any drugs you may be taking and any side effects you may be experiencing
The color and coating of your tongue and the quality of your pulse will be recorded
Once a week you will also be asked to complete the same 3 questionnaires as you did at the beginning of the study
Most study visits will last about 1 hour On the weeks that you complete the questionnaires it may add about 15-20 minutes
During the study you may still receive your regular pain treatments If you are receiving Neurontin gabapentin Cymbalta duloxetine andor Lyrica pregabalin you must stay on the same drugs until you go off this study Minor changes in the doses of your pain treatments are allowed but if there is a large change you will be taken off study early
Length of Study Participation
You may receive up to 21 acupuncture sessions over 13 weeks If intolerable side effects or symptoms occur you will be taken off study early
End-of-Study Visit
At Week 13 or if you go off study early for any reason you will have an end-of-study visit If the doctor thinks it is necessary the following procedures will be performed
Your medical history will be recorded
Your vital signs will be measured
You will be asked about any drugs you may be taking and any side effects you may have experienced
You will complete the same 3 questionnaires as before
The 4 nerve tests will be repeated in order to learn if there have been any changes in your nerve function
Your tongue and pulse will be evaluated
After the end-of-study visit your participation in this study will be over
This is an investigational study The acupuncture needles used in this study are commercially available and FDA approved It is considered experimental however to use acupuncture to treat numbness andor tingling in the feet andor hands that is related to chemotherapy
Up to 30 patients will take part in this study All will be enrolled at The University of Texas UT MD Anderson Cancer Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None