Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048471
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2020-03-02
Brief Title:
High Tone Therapy for Chemotherapy Induced Neuropathy
Sponsor:
Vienna Hospital Association
Organization:
Vienna Hospital Association
Study Overview
Official Title:
High Tone Therapy for Chemotherapy Induced Neuropathy
Status:
COMPLETED
Status Verified Date:
2023-10
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:
Chemotherapy-induced peripheral neuropathy CIPN a side effect of antineoplastic medication was reported to occur in about 68 of the patients receiving chemotherapy CIPN does not only limit quality of life due to neuropathic symptoms but also may lead to dose reductions or premature interruption of therapy and thus to suboptimal cancer treatment
Patients with neuropathy suffer from sensory disturbances as tingling numbness burning pain or sleep disturbances and even though numerous drugs are available it is still difficult to sufficiently control these Symptoms
High tone therapy high tone external muscle stimulation HTEMS seems to be an effective treatment for neuropathic symptoms Previous studies observed promising results in diabetics and chronic kidney disease CKD patients
To date there is no investigation on HTEMS in patients with chemotherapy induced neuropathy
Therefore this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group compared to a placebo treatment
The primary objective is the alleviation of paresthesias The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life
Patients with neuropathy suffer from sensory disturbances as tingling numbness burning pain or sleep disturbances and even though numerous drugs are available it is still difficult to sufficiently control these Symptoms
High tone therapy high tone external muscle stimulation HTEMS seems to be an effective treatment for neuropathic symptoms Previous studies observed promising results in diabetics and chronic kidney disease CKD patients
To date there is no investigation on HTEMS in patients with chemotherapy induced neuropathy
Therefore this aim of this project is to test if HTEMS would bring about a stronger decrease in neuropathic symptoms in this specific patient group compared to a placebo treatment
The primary objective is the alleviation of paresthesias The secondary objective focuses on detailed symptoms of neuropathiy as well as on health-related quality of life
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None