Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

— Bootcamp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411787
• Other study ID #: 122010-150
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: April 3, 2018

Study information

• Verified date: May 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 3, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Pathologic complete response rate	The rate of pathologic complete response at the primary tumor site from the standard 15% to >20%.	post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start

External Links

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