Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/12/2018 |
| Start Date: | March 2009 |
| End Date: | April 3, 2018 |
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.
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.
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.
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