Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer "Can we Kick Down Ki-67, Punch Out Insulin Resistance, and Increase Survival?"
The exercise protocol will consist of activities including walking/running 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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Ki-67 index
Ki-67 has significant value for predicting survival and recurrence risk in breast cancer. A recent study reveals that patients with a post-neoadjuvant chemotherapy Ki-67 index of less than 1.0% had significantly improved survivals when compared to patients with a Ki-67 index > 1.0%
post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start
No
Roshni Rao, MD
Principal Investigator
UT Southwestern Medical Center
United States: Institutional Review Board
SCCC-05108
NCT01411787
March 2009
May 2011
Name | Location |
---|---|
Ut Southwestern Medical Center | Dallas, Texas 75390 |