Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer

NCT01411787 | Completed

• 1 other identifier: 122010-150
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast cancer; neoadjuvant chemotherapy; exercise; Ki-67

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pathologic complete response rate

  post-neoadjuvant chemotherapy; ~ 4-6 months from treatment start

Study Arms (2)

Control Group

NO INTERVENTION

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.

Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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.

Exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Roshni Rao, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 8, 2011
• Study Start: March 1, 2009
• Primary Completion: April 3, 2018
• Study Completion: April 3, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)