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Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01411787
First received: August 2, 2011
Last updated: September 17, 2014
Last verified: September 2014

August 2, 2011
September 17, 2014
March 2009
March 2015   (final data collection date for primary outcome measure)
Ki-67 index [ Time Frame: post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start ] [ Designated as safety issue: No ]
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%
Same as current
Complete list of historical versions of study NCT01411787 on ClinicalTrials.gov Archive Site
Pathologic complete response rate [ Time Frame: post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start ] [ Designated as safety issue: No ]
The rate of pathologic complete response at the primary tumor site from the standard 15% to >20%.
Same as current
Not Provided
Not Provided
 
Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer
Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer "Can we Kick Down Ki-67, Punch Out Insulin Resistance, and Increase Survival?"

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 Women's 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, muscular/circuit 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 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
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Breast Cancer
Behavioral: Exercise
Five woman undergoing neoadjuvant chemotherapy for breast cancer will be randomized to an exercise protocol supervised by an experienced personal trainer. The exercise will be administered three times a week for the 4-6 months of neoadjuvant chemotherapy. The exercise protocol will consist of activities including walking/running up to a mile, calisthenics, and light weightlifting.
  • No Intervention: Control Group
    Patient will continue normal activities. Ki-67 will be measured in the initial core biopsy and then again in the final pathologic specimen which is removed for definitive surgical intervention. Insulin resistance levels will be measured by obtaining insulin-like growth factor binding protein one and C-peptide levels just prior to initiation of neoadjuvant chemotherapy, and then again after the last chemotherapy dose. Body mass index, percent body fat, and improving fitness levels will also be measured.
  • Experimental: Exercise

    Five woman undergoing neoadjuvant chemotherapy for breast cancer will be randomized to an exercise protocol supervised by an experienced personal trainer. The exercise will be administered three times a week for the 4-6 months of neoadjuvant chemotherapy. The exercise protocol will consist of activities including walking/running up to a mile, calisthenics, and light weightlifting.

    Ki-67 will be measured in the initial core biopsy specimen and then again in the final pathologic specimen which is removed for definitive surgical intervention. Insulin resistance levels will be measured by obtaining insulin-like growth factor binding protein one and C-peptide levels just prior to inititation of neoadjuvant chemotherapy and then again after the last chemotherapy dose in both arms. Body mass index, percent body fat, and improving fitness levels will also be measured.

    Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01411787
122010-150
No
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Roshni Rao, MD UT Southwestern Medical Center
University of Texas Southwestern Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP