Clinical trial NCT01411787: Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer
Official title: Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer "Can we Kick Down Ki-67, Punch Out Insulin Resistance, and Increase Survival?"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
neoadjuvant chemotherapy
exercise
Ki-67
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
measure: Ki-67 index
timeFrame: post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start
Secondary outcomes:
measure: Pathologic complete response rate
timeFrame: post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Roshni Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: