Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer (Bootcamp)
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Texas
-
Dallas、Texas、美国、75390
- UT Southwestern Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Receiving neoadjuvant chemotherapy for breast cancer at one of the UT Southwestern hospitals or affiliates (Simmons Cancer Center, Parkland Hospital)
- No evidence of metastatic disease as confirmed by routine staging
- 18 - 70 year old female
- Karnofsky score >80%
- Body Mass Index >25 kg/m2
- Able to speak, read and understand the English language
- Ability to understand and willingness to sign a written informed consent document
- All races and ethnicities will be eligible.
Exclusion Criteria:
- Unable to speak, read and understand the English language
- Patients may not be involved in other trials evaluating the efficacy of neoadjuvant therapy
- Insulin-dependent diabetic patients.
- Known to be pregnant or planning to become pregnant during the study.
- Subjects are prohibited from being on other cancer treatments aside from what their treating medical oncologist has prescribed, primarily additional chemotherapies.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：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.
|
|
|
实验性的：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. |
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ki-67 index
大体时间：post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pathologic complete response rate
大体时间：post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start
|
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
|
合作者和调查者
调查人员
- 首席研究员：Roshni Rao, MD、UT Southwestern Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.