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: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer "Can we Kick Down Ki-67, Punch Out Insulin Resistance, and Increase Survival?"

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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%


Secondary Outcome Measures:
  • 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%.


Enrollment: 10
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Exercise
    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.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411787

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Roshni Rao, MD UT Southwestern Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01411787     History of Changes
Other Study ID Numbers: 122010-150
Study First Received: August 2, 2011
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Breast cancer
neoadjuvant chemotherapy
exercise
Ki-67

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014