Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03145727
Status:
UNKNOWN
Last Update Posted:
2017-08-22
First Post:
2017-05-05
Brief Title:
Electric Stimulation on Nausea and Vomit Chemotherapy Induced
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
Official Title:
Transcutaneous Electric Nerve Stimulation Effects on Nausea and Vomit Chemotherapy-induced
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
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:
TENS-NV
Brief Summary:
Chemotherapy induces nausea and vomit for some large patients But some chemotherapy protocol has a high indices of the incidence as observed in a combination of Anthracycline and Cyclophosphamide AC To prevent this symptoms some medication can be used as Ondansetron By other hands the traditional acupuncture on Chinese Medicine have been used a PC6 point to avoid nausea and vomit More recently a transcutaneous electric nerve stimulation TENS also has been used for this application Our study will test the TENS applied on PC6 point with two different frequencies high and low to evaluated the nausea and vomit inhibition effects
Detailed Description:
We will enroll 84 women that being starts a chemotherapy protocol with a Anthracycline and Cyclophosphamide AC as a part of breast cancer treatment All volunteers will be submitted a 30 minutes TENS prior to chemotherapy administration Three different TENS treatment will be test 1 placebo 2 high frequency and 3 low frequency The self-adhesive electrodes will be positioned in the same position for all different TENS treatment opposite arm to the chemotherapy infusion The eletctrodes will be positioned as follows the first electrode at the PC6 point which is located proximal to the flexion fold of the wrist in the middle of the anterior face of the forearm between the tendons of the long palmar and radial flexor muscles of the carpus and the second electrode at any point in the hand After that all volunteers will receipt a formulary to self-complete a nausea and vomit symptoms record during the next 24 hours Number of incidence and magnitude of the symptoms will express the accumulated indices the occurrence and severity of the symptoms as further describe in this protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None