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Breast Tumor Oxygenation During Exercise

This study is currently recruiting participants.
Verified February 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02340468
First Posted: January 16, 2015
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
In the field of cancer treatment, it is generally accepted that the enhancement of oxygen delivery to tumors can augment the effect of anti-cancer therapies. In the case of chemotherapy, this enhancement might lead to a larger amount of a given dose of treatment reaching the tumor and having an effect.

Condition Intervention
Breast Tumor Device: diffuse optical spectroscopy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Breast Tumor Oxygenation During Exercise

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Measure breast tumor oxygenation [ Time Frame: up to 12 weeks ]

Estimated Enrollment: 30
Study Start Date: April 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: diffuse optical spectroscopy
    diffuse optical spectroscopy
Detailed Description:

While the benefits of exercise on overall health are widely documented, little is known about how exercise affects the progression or treatment of malignant neoplasms. Tumors have a complex vascular network which is likely affected by the global changes in hemodynamics and perfusion that occur during moderate exercise. Increased tumor oxygenation is clinically relevant as it may counteract the hypoxic tumor environment which is known to contribute to resistance to chemo- and radiation therapies, angiogenesis, invasiveness and metastasis, genomic instability, and resistance to cell death.

The researcher can use noninvasive optical imaging technology called diffuse optical spectroscopy to safely and non-invasively quantify the dynamics of blood flow and metabolism in tumors and normal tissue of subjects undergoing supervised cycling exercise. The researcher can determine that exercise will measurably increase tumor oxygenation, and that this effect will be proportional to the intensity and/or duration of the exercise performed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study population will be recruited from an outpatient at UC Irvine Health
Criteria

Inclusion Criteria:

  • Tumor group, female, Greater than 21 years of age but less than 70 years of age, Current diagnosis of breast cancer stage 0 - IV or radiologically suspicious for breast cancer BI-RADS score 4 or 5.
  • Control group,Female, Greater than 21 years of age but less than 70 years of age, Not currently diagnosed with breast cancer

Exclusion Criteria:

  • Under 21 years of age, Pregnant or breastfeeding, Contraindications for moderate exercise, history of heart, pulmonary, or musculoskeletal disease; physician instructions to restrict physical activity.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340468


Contacts
Contact: Ata Sharif, MD, MBA 949.824.9265 sharifs@uci.edu

Locations
United States, California
Beckman Laser Institute Medical Clinic Recruiting
Irvine, California, United States, 92612
Contact: Ata Sharif, MD, MBA    949-824-9265    sharifs@uci.edu   
Sub-Investigator: Goutham Ganesan, BS         
Sub-Investigator: Anais Leproux, PhD         
Sub-Investigator: Ylenia Santoro, PhD         
Sub-Investigator: Amanda Durkin, BS         
Sub-Investigator: Robert Warren, BS         
Sub-Investigator: Jennifer Ehren, PhD         
Sub-Investigator: Thomas O'Sullivan, PhD         
Principal Investigator: Bruce Tromberg, PhD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Bruce Tromberg, PhD Beckman Laser Institute
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Bruce Tromberg,Ph.D.,Director, Beckman Laser Institute and Medical Clinic and Professor, Departments of Biomedical Engineering and Surgery, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02340468     History of Changes
Other Study ID Numbers: NIH/LAMMP-2014-1505
First Submitted: January 13, 2015
First Posted: January 16, 2015
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases