Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405678
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2006-11-29
Brief Title:
Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer A Phase I-II Study
Status:
COMPLETED
Status Verified Date:
2013-07
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:
None
Brief Summary:
To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy
Detailed Description:
Given that this is the first study to explore the potential effects of exercise training on exercise capacity tumor vascularity and response in women undergoing neoadjuvant chemotherapy for operable breast cancer prior to the initiation of the full investigation we will conduct a small vanguard study to ensure we can achieve acceptable exercise adherence rates in the absence of dose-limiting toxicities DLTs Specifically three operable breast cancer patients will be recruited and enrolled as described below and perform exercise training for a minimum of six weeks If acceptable exercise rates are observed in the absence of severe DLTs during this time we will proceed with the full investigation recruitment of additional 20 patients see Figure 2 Using a prospective randomized design potential participants will be identified and screened for eligibility by an assigned Breast Protocol Nurse TBD via medical record review of patients scheduled for their primary neoadjuvant chemotherapy consultation at DCCC
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 8426 | OTHER | Duke legacy protocol number | None |