Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01411787
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2011-08-02
Brief Title:
Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer Can we Kick Down Ki-67 Punch Out Insulin Resistance and Increase Survival
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Bootcamp
Brief Summary:
This is a randomized single-site pilot study incorporating one control group This research involves an exercise group and a non-exercise group control group
The patients who are in the exercise group will be enrolled in the Dallas County Womens Adventure Boot Camp This will require them to undergo exercise training 3 times per week under the direction of an experienced personal trainer in a group setting All Boot Camp personal trainers are trained in basic cardiac life support CPR and are trained to watch for any signs or symptoms associated with a poor exercise response
The investigators hypothesize that randomizing women to a supervised exercise program of core conditioning muscularcircuit training and short distance running administered during neoadjuvant chemotherapy for breast cancer can be performed
Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their breast cancer This will be about 4 - 6 months
The patients who are in the exercise group will be enrolled in the Dallas County Womens Adventure Boot Camp This will require them to undergo exercise training 3 times per week under the direction of an experienced personal trainer in a group setting All Boot Camp personal trainers are trained in basic cardiac life support CPR and are trained to watch for any signs or symptoms associated with a poor exercise response
The investigators hypothesize that randomizing women to a supervised exercise program of core conditioning muscularcircuit training and short distance running administered during neoadjuvant chemotherapy for breast cancer can be performed
Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their breast cancer This will be about 4 - 6 months
Detailed Description:
The exercise protocol will consist of activities including walkingrunning up to a mile calisthenics jumping jacks short relays rapid punches and light no greater than 5 pounds weight lifting The patients who do not receive the exercise program will be allowed to do what they would normally do during their neoadjuvant chemotherapy They are allowed to engage in their own exercise regimens and diet modifications
Subjects will receive the chemotherapy as directed by their physicians and then undergo surgery as planned Randomization will occur by drawing cards entitled exercise or control from an envelope and then assigning the patient to this group
Subjects will receive the chemotherapy as directed by their physicians and then undergo surgery as planned Randomization will occur by drawing cards entitled exercise or control from an envelope and then assigning the patient to this group
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