Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583124
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2020-10-05
Brief Title:
Adjusting the Dose of Therapeutic Exercise to Prevent Neurotoxicity Due to Anticancer Treatment ATENTO
Sponsor:
Universidad de Granada
Organization:
Universidad de Granada
Study Overview
Official Title:
Neurotoxicity Prevention With a Multimodal Program ATENTO Prior to Cancer Treatment Versus Throughout Cancer Treatment in Women Newly Diagnosed for Breast Cancer a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ATENTO
Brief Summary:
The purpose of this study is to determine whether a multimodal program based on therapeutic exercise and vagal activation techniques for newly diagnosed breast cancer women has better results in terms of neurotoxicity prevenion before or during medical treatments
Detailed Description:
One of the most common side effects of breast cancer and its treatments is neurotoxicity of central and peripheral nervous system Neurotoxicity is present in up to 75 of this population which implies a large impact in quality of life There is a special interest in the preventive possibilities of therapeutic exercise relating to these neurological sequelae whose benefits could improve thanks to the combination with vagal activation techniques
This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention ATENTO based on moderate-high intensity and individualized therapeutic exercise aerobic and strength exercises and vagal activation techniques myofascial stretching and breathing exercises on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments ATENTO-B versus throughout them ATENTO-T A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85 will be allocated into two groups
This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments
This superiority randomized controlled trial will be aimed to check the effects of a multimodal intervention ATENTO based on moderate-high intensity and individualized therapeutic exercise aerobic and strength exercises and vagal activation techniques myofascial stretching and breathing exercises on neurotoxicity prevention in women with breast cancer before starting potentially neurotoxic treatments ATENTO-B versus throughout them ATENTO-T A sample of 56 women newly diagnosed with breast cancer calculated with a power of 85 will be allocated into two groups
This study could provide an impetus for the introduction of early multimodal intervention methods of preventing neurotoxicity and consequently avoid the current QoL deterioration that breast cancer patients suffer throughout their treatments
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