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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: 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.
|
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ki-67 index
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pathologic complete response rate
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Roshni Rao, MD, UT Southwestern Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 122010-150
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Bröstcancer
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital och andra samarbetspartnersAvslutadDen kliniska tillämpningsguiden för Conebeam Breast CTKina
-
ETOP IBCSG Partners FoundationAvslutadBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAvslutadBreast Cancer Invasive NosSpanien
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...OkändBRCA1-mutation | Breast Cancer Invasive NosPolen
-
University Health Network, TorontoAvslutadBreast Cancer Invasive Nos | Primär invasiv bröstcancerKanada
-
Novartis PharmaceuticalsAvslutadMetastaserad bröstcancer (MBC) | Locally Advance Breast Cancer (LABC)Storbritannien, Spanien
-
McMaster UniversityCanadian Breast Cancer FoundationAvslutadBreast Cancer Invasive Nos | Steg 0 BröstkarcinomKanada