Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536556
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-05-13
Brief Title:
Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients Comparison of Paclitaxel vs Paclitaxel Trastuzumab vs Paclitaxel Carboplatine the PROTECT-06 Bis Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients Comparison of Paclitaxel vs Paclitaxel Trastuzumab vs Paclitaxel Carboplatine the PROTECT-06 Bis Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTECT-06-bis
Brief Summary:
This study aims to investigate the acute effects ie 4 days of paclitaxel or paclitaxel vs trastuzumab or paclitaxel and carboplatine on skeletal muscle of breast cancer patients Muscle biopsies will be performed as well as measurements of body composition strength muscle architecture and quality of life
Detailed Description:
Breast cancer patients are commonly treated with chemotherapy which is known to induce severe side effects such as skeletal muscle deconditioning characterized by skeletal muscle atrophy and major mitochondrial alterations These maladaptations observed in patients treated with epirubicin-cyclophosphamide EC followed by weekly paclitaxel TAX ultimately lead to reduction in exercise capacity and quality of life However little is known about the specific effect of each type of chemotherapy
In our recent article see Citations field in the References module The investigators demonstrated that chemotherapy effects on skeletal muscle are drug-dependent Using muscle biopsies before and 4 days after the first administration of EC or TAX we demonstrated that unlike TAX EC induced severe muscle atrophy and mitochondrial alterations Of note patients in the TAX group had already received EC during the preceding weeks Figure 1 Therefore these patients had already begun to have altered skeletal muscle homeostasis which might have limited the influence of TAX compared with that of its administration in isolation ie without other previous chemotherapy administrations In addition some patients had received concomitantly with TAX Trastuzumab TRASTU due to HER tumor mutation Also in triple negative breast cancers the recommendations concerning neoadjuvant chemotherapy have recently changed and recommend starting treatment with the use of paclitaxel carboplatin TAX CARBO
In our recent article see Citations field in the References module The investigators demonstrated that chemotherapy effects on skeletal muscle are drug-dependent Using muscle biopsies before and 4 days after the first administration of EC or TAX we demonstrated that unlike TAX EC induced severe muscle atrophy and mitochondrial alterations Of note patients in the TAX group had already received EC during the preceding weeks Figure 1 Therefore these patients had already begun to have altered skeletal muscle homeostasis which might have limited the influence of TAX compared with that of its administration in isolation ie without other previous chemotherapy administrations In addition some patients had received concomitantly with TAX Trastuzumab TRASTU due to HER tumor mutation Also in triple negative breast cancers the recommendations concerning neoadjuvant chemotherapy have recently changed and recommend starting treatment with the use of paclitaxel carboplatin TAX CARBO
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