Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06455904
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Study Overview
Official Title:
Effects Of Concentric Cycling Training Protocol During (Neo)Adjuvant Chemotherapy in Breast Cancer Patients: PROTECT-07 Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PROTECT-07
Brief Summary:
The association of anthracyclines (ANT) and paclitaxel (Tax) is one of the main treatments used in breast cancer. These treatments are known to induce severe side effects such as a decrease in overall exercise capacity (physical condition) in response to muscle and cardiorespiratory alterations. If exercise may be an effective preventive strategy, it seems important to prescribe the most efficient exercise modality. Among them, concentric cycling (i.e., classic cycling) can significantly induce metabolic stimulus, which is needed for maintaining exercise capacity. The PROTECT-07 study aims to demonstrate the superiority of a training program based on concentric cycling during chemotherapy compared to standard treatment. The duration of the training program is 15 weeks with one session per week.
Detailed Description:
There will be two groups of patients after drawing lots using a process called randomization. The probability is one in two of being in the group participating in the training program, the other group following the standard treatment.
Study Oversight
Has Oversight DMC:
False
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?: