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Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer "Can we Kick Down Ki-67, Punch Out Insulin Resistance, and Increase Survival?"


N/A
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



1. Receiving neoadjuvant chemotherapy for breast cancer at one of the UT Southwestern
hospitals or affiliates (Simmons Cancer Center, Parkland Hospital)

2. No evidence of metastatic disease as confirmed by routine staging

3. 18 - 70 year old female

4. Karnofsky score >80%

5. Body Mass Index >25 kg/m2

6. Able to speak, read and understand the English language

7. Ability to understand and willingness to sign a written informed consent document

8. All races and ethnicities will be eligible.

Exclusion Criteria:

1. Unable to speak, read and understand the English language

2. Patients may not be involved in other trials evaluating the efficacy of neoadjuvant
therapy

3. Insulin-dependent diabetic patients.

4. Known to be pregnant or planning to become pregnant during the study.

5. Subjects are prohibited from being on other cancer treatments aside from what their
treating medical oncologist has prescribed, primarily additional chemotherapies.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Ki-67 index

Outcome Description:

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%

Outcome Time Frame:

post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start

Safety Issue:

No

Principal Investigator

Roshni Rao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT Southwestern Medical Center

Authority:

United States: Institutional Review Board

Study ID:

SCCC-05108

NCT ID:

NCT01411787

Start Date:

March 2009

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • neoadjuvant chemotherapy
  • exercise
  • Ki-67
  • Breast Neoplasms

Name

Location

Ut Southwestern Medical CenterDallas, Texas  75390